INTERVENTIONALCOMPLETEDNCT02224560

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.

The primary objective of this study was to evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo in participants with Lennox-Gastaut syndrome (LGS).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-09-28

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 225 (ACTUAL)
Start date: 2015-06-08
Sponsor: Jazz Pharmaceuticals
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 29
Results record: Present in registry snapshot

This study was a 1:1:1 randomized, double-blind, 14-week comparison of 2 dose levels (10 milligram \[mg\] per kilogram \[kg\] per day \[mg/kg/day\] and 20 mg/kg/day) of GWP42003-P versus placebo. Participants who satisfied all inclusion and none of the exclusion criteria began a 28-day baseline observation period. The treatment period consisted of a 2-week titration period followed by a 12-week maintenance period. The 20 mg/kg/day dose was recommended by the Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206). The 10 mg/kg/day dose was defined as 50% of the 20 mg/kg/day dose. The first participant was not enrolled into this study until the DSMC had reviewed the safety data from Part A of study GWEP1332. Participants who satisfied all eligibility criteria were randomized at Day 1 to receive 10 mg/kg/day GWP42003-P, 20 mg/kg/day GWP42003-P, or placebo at a 1:1:1 ratio. Participants in the placebo group were split into 2 equivalent cohorts; one half received 10 mg/kg/day dosing volumes and one half received 20 mg/kg/day dosing volumes. The 2 placebo cohorts were pooled for the analyses of efficacy. Participants titrated GWP42003-P to the 10 mg/kg/day or 20 mg/kg/day (or equivalent volume of placebo) dose over 7 and 11 days, respectively, and remained at this dose for the 12-week maintenance period. Following the end of treatment (Day 99), participants were invited to continue to receive GWP42003-P in an open-label extension (OLE) study under a separate protocol (GWEP1415; NCT02224573). All participants who did not immediately enter the OLE study tapered investigational medicinal product (IMP) (10% per day over 10 days). However, the taper period could be interrupted if the participant wished to enter the OLE study within a 7-day timeframe. Participants who down-titrated IMP returned for an end of taper period visit (Day 109). Participants who did not enter the OLE study or who withdrew prematurely had a safety follow-up visit 28 days later (Day 137).

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Interventions

What was registered

DRUG

GWP42003-P

GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 10 or 20 mg/kg/day.

Cannabidiol · Epidiolex

DRUG

Placebo control

Placebo was presented as an oral solution containing 0 mg/mL CBD in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).

Placebo

Source-reported results

Results posted to the registry

4 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 3
Statistical analyses: 8
Adverse-event terms: 47

PRIMARYPercentage Change From Baseline In Drop Seizure Frequency During The Treatment Period

Time frame: Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)
Measure: MEDIAN · percentage change
Reporting status: POSTED

Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: (\[frequency during the treatment period - frequency during baseline\]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline.

Population: ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.

Group	N	Value	Spread / interval
GWP42003-P 20 mg/kg/Day Dose	76	-41.86	-72.4 to -1.3
GWP42003-P 10 mg/kg/Day Dose	73	-37.16	-63.8 to -5.6
Placebo	76	-17.17	-37.1 to 0.9

Statistical analyses

GWP42003-P 20 mg/kg/Day Dose vs PlaceboWilcoxon rank-sum testMedian Difference (Final Values): -21.57p-value: 0.0047

Eligibility

Population and criteria

Sex: ALL
Minimum age: 2 Years
Maximum age: 55 Years
Healthy volunteers: Not accepted

Inclusion criteria

Participant and/or parent(s)/legal representatives were willing and able to give informed assent/consent for participation in the study.
Participant and his or her caregivers were willing and able (in the investigator's opinion) to comply with all study requirements.
Participant was male or female aged between 2 and 55 years (inclusive).
Participant had a documented history of LGS. This included written documentation of having met electroencephalogram (EEG) diagnostic criteria during the participant's history and evidence of at least 1 type of generalized seizure, including drop seizures (atonic, tonic, tonic-clonic or myoclonic) for at least 6 months.
Participant had a history of slow (\<3.0 hertz \[Hz\]) spike-and-wave pattern in an EEG prior to the enrollment into the baseline period.
Participant had at least 2 drop seizures each week during the first 28 days of the baseline period.
Participant was refractory; that is having documented failures on more than 1 antiepileptic drug (AED).
Participant was taking 1 or more AEDs at a dose which had been stable for at least 4 weeks prior to screening.
All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation \[VNS\]) were stable for 4 weeks prior to screening and the participant was willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments were not counted as an AED.
Participant and/or parent(s)/legal representatives were willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
Participant completed his or her interactive voice response (IVRS) telephone diary on at least 25 days of the baseline period.

Exclusion criteria

Etiology of participant's seizures was a progressive neurologic disease. Participants with tuberous sclerosis were not excluded from study participation, unless there was a progressive tumor.
Participant had an anoxic episode requiring resuscitation within 6 months of screening.
Participant had clinically significant unstable medical conditions other than epilepsy.
Participant had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or randomization, other than epilepsy.

primary outcomes

primary measures

Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period

Time frame: Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)

secondary outcomes

secondary measures

Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period

Time frame: Baseline to EOT (Day 99) or ET

Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic, or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure.

Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period

Time frame: Baseline to EOT (Day 99) or ET

Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline.

Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment

Time frame: Baseline to Last Visit (Day 99) or ET

The S/CGIC was used to assess the participant's overall condition on a 7-point scale, using the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse" (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed.

Publications

Locally readable linked articles

linked publication

Clinically Meaningful Reduction in Drop Seizures in Patients with Lennox-Gastaut Syndrome Treated with Cannabidiol: Post Hoc Analysis of Phase 3 Clinical Trials.

CNS Drugs · Free full text · non-commercial reuse

Snapshot provenance

Snapshot: cf08bbd9-e8d2-4fc4-ba52-0ea4832b4234
Retrieved: 11/09/2026, 14:16:35
SHA-256: 3a867e6d6877e5488b86be556c3778b2d78ba86bf23e2bfb21d415395b83b755

Event	System	Groups: affected / at risk
Lymphopenia	Blood and lymphatic system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Constipation	Gastrointestinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Pneumatosis intestinalis	Gastrointestinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Pancreatitis	Gastrointestinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Faecaloma	Gastrointestinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 1 / 76
Device malfunction	General disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Pyrexia	General disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Cholecystitis chronic	Hepatobiliary disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Pneumonia	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 2 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 3 / 67 · Placebo-Safety Analysis Set: 0 / 76
Adenovirus infection	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Pneumonia mycoplasmal	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Respiratory syncytial virus infection	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Upper respiratory tract infection	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Pneumonia bacterial	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Pneumonia respiratory syncytial viral	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Tracheobronchitis	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 1 / 76
Delayed recovery from anaesthesia	Injury, poisoning and procedural complications	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Aspartate aminotransferase increased	Investigations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Alanine aminotransferase increased	Investigations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Gamma-glutamyltransferase increased	Investigations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Transaminases increased	Investigations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Investigation	Investigations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 1 / 76
Dehydration	Metabolism and nutrition disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Status epilepticus	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 4 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 7 / 67 · Placebo-Safety Analysis Set: 3 / 76
Convulsion	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 2 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Lethargy	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Somnolence	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Sedation	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Nephrolithiasis	Renal and urinary disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 1 / 76
Pleural effusion	Respiratory, thoracic and mediastinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76
Hypoxia	Respiratory, thoracic and mediastinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 1 / 76
Hypoventilation	Respiratory, thoracic and mediastinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 0 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 1 / 67 · Placebo-Safety Analysis Set: 0 / 76
Hypotension	Vascular disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 1 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 0 / 67 · Placebo-Safety Analysis Set: 0 / 76

Event	System	Groups: affected / at risk
Diarrhoea	Gastrointestinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 12 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 7 / 67 · Placebo-Safety Analysis Set: 6 / 76
Vomiting	Gastrointestinal disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 10 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 4 / 67 · Placebo-Safety Analysis Set: 9 / 76
Pyrexia	General disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 9 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 6 / 67 · Placebo-Safety Analysis Set: 12 / 76
Fatigue	General disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 8 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 5 / 67 · Placebo-Safety Analysis Set: 2 / 76
Upper respiratory tract infection	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 10 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 11 / 67 · Placebo-Safety Analysis Set: 11 / 76
Nasopharyngitis	Infections and infestations	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 9 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 3 / 67 · Placebo-Safety Analysis Set: 5 / 76
Decreased appetite	Metabolism and nutrition disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 21 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 11 / 67 · Placebo-Safety Analysis Set: 6 / 76
Somnolence	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 25 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 14 / 67 · Placebo-Safety Analysis Set: 4 / 76
Lethargy	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 5 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 3 / 67 · Placebo-Safety Analysis Set: 2 / 76
Convulsion	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 5 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 2 / 67 · Placebo-Safety Analysis Set: 7 / 76
Headache	Nervous system disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 5 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 2 / 67 · Placebo-Safety Analysis Set: 3 / 76
Irritability	Psychiatric disorders	GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set: 4 / 82 · GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set: 6 / 67 · Placebo-Safety Analysis Set: 2 / 76

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults.

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

GWP42003-P

Placebo control

Results posted to the registry

Statistical analyses

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period

secondary measures

Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period

Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period

Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment

Locally readable linked articles

Clinically Meaningful Reduction in Drop Seizures in Patients with Lennox-Gastaut Syndrome Treated with Cannabidiol: Post Hoc Analysis of Phase 3 Clinical Trials.

Statistical analyses

Statistical analyses

Statistical analyses

Overall Study

Age, Continuous

Sex: Female, Male

GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set

GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set

Placebo-Safety Analysis Set

Group	N	Value	Spread / interval
GWP42003-P 20 mg/kg/Day Dose	76	-38.40	-64.6 to -0.7
GWP42003-P 10 mg/kg/Day Dose	73	-36.44	-64.5 to -10.8
Placebo	76	-18.47	-39.0 to 0.5

Milestone	GWP42003-P 20 mg/kg/Day Dose	GWP42003-P 10 mg/kg/Day Dose	Placebo
STARTED	76	73	76
Safety Analysis Set	82	67	76
Intent to Treat (ITT) Analysis Set	76	73	76
COMPLETED	67	71	74
NOT COMPLETED	9	2	2