Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
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This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion. Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant seizures, and satisfy all inclusion/exclusion criteria.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2017-06-23
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Population: Pharmacokinetic population (PK), all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 59.03 | 99.98 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 110.5 | 142.3 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 256.9 | 351.9 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 28.71 | 26.72 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 61.89 | 72.88 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 |
Eligibility
primary outcomes
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Publications
| 140.9 |
| 210.0 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 119.6 | 105.0 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 220.0 | 294.7 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 426.8 | 327.7 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 79.38 | 40.82 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 136.6 | 140.9 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 286.1 | 201.9 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 11.72 | 19.89 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 10.77 | 13.97 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 13.25 | 18.07 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 5.737 | 5.330 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 5.990 | 7.011 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 7.286 | 10.91 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 23.79 | 20.46 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 21.16 | 28.40 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 21.40 | 16.38 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 15.82 | 7.928 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 13.10 | 13.06 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 14.39 | 10.26 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 2.58 | 1.02 to 8.00 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 4.00 | 1.00 to 8.08 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 3.15 | 1.00 to 24.02 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 2.55 | 1.00 to 6.08 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 4.00 | 1.00 to 11.95 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 3.07 | 1.00 to 12.05 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 2.99 | 1.00 to 4.25 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 2.00 | 0.00 to 6.00 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 3.00 | 0.00 to 6.02 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 2.08 | 1.00 to 4.08 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 2.03 | 1.00 to 6.05 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 2.03 | 0.00 to 5.90 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for t1/2.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 31.31 | 23.46 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 33.48 | 14.97 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 21.58 | 10.50 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 19.71 | 7.640 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 31.84 | 24.28 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 14.77 | 4.354 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for λz.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 0.02969 | 0.01386 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 0.02836 | 0.02340 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 0.03949 | 0.01976 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 0.04053 | 0.01557 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 0.03276 | 0.01985 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 0.05123 | 0.01711 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for CL/F.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 10 | 29.78 | 15.96 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 8 | 21.10 | 23.04 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 12 | 31.29 | 30.43 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Vz/F.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 10 | 1021 | 609.1 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 8 | 930.8 | 1034 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 12 | 982.6 | 1119 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 173.9 | 179.6 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 507.1 | 687.7 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 914.5 | 1155 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 124.4 | 80.18 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 329.8 | 402.9 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 646.7 | 886.3 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 34.60 | 35.48 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 49.23 | 66.68 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 47.13 | 59.38 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 24.88 | 15.93 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 31.77 | 38.00 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 33.39 | 45.94 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-last).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 250.0 | 217.1 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 692.5 | 826.9 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 1355 | 1447 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 212.2 | 112.1 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 544.9 | 526.6 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 1221 | 1296 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 270.1 | 256.7 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 1140 | 1118 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 1584 | 1709 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 229.3 | 122.3 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 704.1 | 627.8 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 1354 | 1428 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf)/D.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 53.64 | 50.04 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 111.8 | 111.2 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 83.10 | 87.93 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 46.07 | 24.63 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 68.43 | 62.34 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 70.34 | 73.66 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose. MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRCmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 0.8935 | 0.5543 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 0.9328 | 0.8332 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 0.8081 | 0.4849 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for metabolite to parent ratio.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 0.7717 | 0.3960 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 17 | 0.8230 | 0.3880 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 0.7657 | 0.4179 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis. MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-inf).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 10 | 0.9099 | 0.5173 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 8 | 0.9459 | 0.4874 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 12 | 0.9538 | 0.4370 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose. MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 0.9309 | 0.5229 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 19 | 0.9793 | 0.7147 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 0.9085 | 0.5075 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Population: Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 19 | 0.8795 | 0.4084 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 17 | 0.7866 | 0.2361 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 0.8700 | 0.4304 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 581.6 | 283.4 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 1098 | 976.4 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 2708 | 1789 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 513.4 | 269.0 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 832.8 | 675.2 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 2165 | 1405 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 115.8 | 55.32 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 106.0 | 94.64 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 135.7 | 89.17 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 102.2 | 53.01 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 80.19 | 63.53 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 108.7 | 70.76 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmin.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 19.97 | 8.798 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 41.67 | 25.41 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 118.3 | 75.82 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 21.82 | 13.23 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 34.11 | 23.99 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 108.7 | 70.87 |
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cavg.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 48.56 | 23.58 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 91.38 | 80.92 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 225.7 | 149.3 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 42.94 | 22.54 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 69.37 | 56.09 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 180.4 | 117.1 |
RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1. Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RCmax.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 5.535 | 5.551 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 4.454 | 4.466 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 7.488 | 11.93 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 3.823 | 2.730 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 3.996 | 3.544 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 5.788 | 6.028 |
RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1. Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RAUC(0-12).
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 5.434 | 3.625 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 5.489 | 4.633 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 9.376 | 15.11 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 4.865 | 2.748 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 4.524 | 3.338 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 7.541 | 7.187 |
Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC\[0-inf\] on Day 1. Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Population: PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for time linearity index.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 3.211 | 2.048 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 2.628 | 2.276 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 4.201 | 4.990 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 15 | 2.500 | 0.9365 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 15 | 1.821 | 1.162 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 16 | 3.045 | 2.260 |
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention.
Population: Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 13 | - |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 9 | - |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 17 | - |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 0 | - |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 1 | - |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 2 | - |
The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.
Population: Efficacy Analysis Population (EFF), all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-I post-dose.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 2.1 | 1.02 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 2.4 | 0.82 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 2.3 | 1.15 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | 2.7 | 0.92 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | 2.5 | 0.94 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 2.9 | 0.91 |
The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant's mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness).
Population: EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-S post-dose.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | -1.7 | 2.08 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | -2.2 | 2.04 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | -1.8 | 1.64 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | -1.1 | 1.27 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | -0.7 | 1.15 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | -0.7 | 1.23 |
The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity.
Population: EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for number of seizures per day at Day 11.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | -0.8 | 1.55 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | -0.8 | 1.59 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | -2.9 | 7.69 |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 20 | -0.2 | 0.98 |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 20 | -0.1 | 0.28 |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 21 | 0.0 | 0.00 |
The C-SSRS captured the occurrence, severity, and frequency of suicide related thoughts and behaviors at Day 11. The C-SSRS was only used for participants ≥ 7 years of age. The number of participants with results of "Yes" for Suicidal Ideation (Wish to be Dead and Non-Specific Active Suicidal Thoughts) and Suicidal Behavior (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior, and Suicidal Behavior) are reported.
Population: Participants from the Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product, who completed the C-SSRS.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 4 | 0 | - |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 5 | 0 | - |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 4 | 0 | - |
| Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | 4 | 0 | - |
| Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | 5 | 0 | - |
| High Dose Cannabidiol Oral Solution [40 mg/kg/Day] | 4 | 0 | - |
| Milestone | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] | Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] | High Dose Cannabidiol Oral Solution [40 mg/kg/Day] |
|---|---|---|---|
| STARTED | 20 | 20 | 21 |
| COMPLETED | 20 | 20 | 21 |
| NOT COMPLETED | 0 | 0 | 0 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Apnoea | Respiratory, thoracic and mediastinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Drug eruption | Skin and subcutaneous tissue disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Thrombophlebitis | Vascular disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 2 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 5 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 4 / 21 |
| Diarrhoea | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 2 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 7 / 21 |
| Flatulence | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 2 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 3 / 21 |
| Abdominal pain upper | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 2 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Vomiting | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 2 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Catheter site pruritus | General disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 2 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Pyrexia | General disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Weight increased | Investigations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 2 / 21 |
| Decreased appetite | Metabolism and nutrition disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 2 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Dehydration | Metabolism and nutrition disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 2 / 21 |
| Metabolic acidosis | Metabolism and nutrition disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 2 / 21 |
| Somnolence | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 3 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 3 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 7 / 21 |
| Psychomotor hyperactivity | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 2 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 3 / 21 |
| Seizure | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Ataxia | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 2 / 21 |
| Insomnia | Psychiatric disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Cough | Respiratory, thoracic and mediastinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 2 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Ecchymosis | Skin and subcutaneous tissue disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Oral mucosal erythema | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Oral pain | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Fatigue | General disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Thirst | General disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Lice infestation | Infections and infestations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Skin abrasion | Injury, poisoning and procedural complications | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Weight decreased | Investigations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Hypersomnia | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Syncope | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Aggression | Psychiatric disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Agitation | Psychiatric disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Irritability | Psychiatric disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Dermatitis | Skin and subcutaneous tissue disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 1 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Nodal rhythm | Cardiac disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Dysphagia | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Injection site reaction | General disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Upper respiratory tract infection | Infections and infestations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Blood follicle stimulating hormone increased | Investigations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Hyperphosphataemia | Metabolism and nutrition disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Hypocalcaemia | Metabolism and nutrition disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Proteinuria | Renal and urinary disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Rash macular | Skin and subcutaneous tissue disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Tachycardia | Cardiac disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Ear pain | Ear and labyrinth disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Eye pain | Eye disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Constipation | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Nausea | Gastrointestinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Catheter site pain | General disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Adenovirus infection | Infections and infestations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Clostridium difficile infection | Infections and infestations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Escherichia urinary tract infection | Infections and infestations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Urinary tract infection | Infections and infestations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 1 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 0 / 21 |
| Blood follicle stimulating hormone decreased | Investigations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Urine analysis abnormal | Investigations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Dizziness | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Headache | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Lethargy | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Sedation | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Tremor | Nervous system disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Asthma | Respiratory, thoracic and mediastinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Pruritus | Skin and subcutaneous tissue disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Hyperglycaemia | Metabolism and nutrition disorders | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
| Alanine aminotransferase increase | Investigations | Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]: 0 / 20 · Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]: 0 / 20 · High Dose Cannabidiol Oral Solution [40 mg/kg/Day]: 1 / 21 |
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose. MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis. MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time frame: Day 1 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose. MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose. MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 10 at age-specific times
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 10 at age-specific times
RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1. Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 10 at age-specific times
RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1. Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 1 to \<2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to \<6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time frame: Day 1 and Day 10
Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC\[0-inf\] on Day 1. Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows: Participants ages 2 to \<6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to \<2 years were not included in this analysis.
Time frame: From the first dose of study drug up to Day 17
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention.
Time frame: Day 11
The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.
Time frame: Baseline and Day 11
The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant's mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness).
Time frame: Baseline and Day 11
The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity.
Time frame: Day 11
The C-SSRS captured the occurrence, severity, and frequency of suicide related thoughts and behaviors at Day 11. The C-SSRS was only used for participants ≥ 7 years of age. The number of participants with results of "Yes" for Suicidal Ideation (Wish to be Dead and Non-Specific Active Suicidal Thoughts) and Suicidal Behavior (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior, and Suicidal Behavior) are reported.