INTERVENTIONALNOT YET RECRUITINGNCT07728097

A Phase 3b/4, Interventional, Prospective, Multicenter, Open-Label Study Evaluating the Effectiveness of a Gradual Titration Regimen to Optimize CBD-OS as Add-On Therapy in Adults With Lennox-Gastaut Syndrome

This is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-08-31

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE4
Enrollment: 40 (ESTIMATED)
Start date: 2026-11-18
Sponsor: Jazz Pharmaceuticals
Design: NA · SINGLE GROUP · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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

Cannabidiol Oral Solution

100 mg/ml Cannabidiol Oral solution (CBD-OS)

JZP926 · CBD-OS · Epidiolex · Epidyolex

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Inclusion criteria

1. Has a confirmed clinical diagnosis of LGS with a history of seizures and actively experiencing seizures within 6 months of screening. 2. Is naïve to CBD-OS treatment or has been off CBD-OS treatment for at least 3 months prior to screening. 3. Is willing to maintain any factors expected to affect seizures (eg, alcohol consumption, smoking, concomitant medication usage) stable for the duration of the study. 4. Is currently treated with at least 1 ASM, but no more than 3 ASMs, and is on a stable regimen for at least 4 weeks prior to screening. 5. Adequate contraceptive precautions 6. Participant has a primary caregiver/legally authorized representative (LAR) who is willing and able, in the investigator's opinion, to participate throughout the duration of the study and to comply with all study requirements 7. Experienced at least 4 or more countable major motor seizures (isolated seizures or seizures occurring in a cluster) during the 5-week Baseline Period preceding treatment. 8. Caregiver completed at least 80% of seizure diary entries during the Baseline Period with no more than 3 consecutive days of missing entries.

Exclusion criteria

1. Has a significant psychiatric illness 2. Has an illness during the 4 weeks prior to screening other than epilepsy which, in the investigator's opinion, could affect study outcomes or seizure frequency. 3. Has history of SE in the 3 months prior to screening. 4. Has any other significant disease other than epilepsy, which, in the investigator's opinion, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study. 5. Has previously undergone significant surgery for epilepsy in the 6 months prior to screening or planned to undergo surgery for epilepsy during the study. 6. Is currently using or has in the past used recreational or medicinal cannabis or synthetic cannabinoid-based medications, products, or supplements within the 3 months prior to screening and is not willing to undergo a 1-month washout period before being rescreened. 7. Has initiated felbamate within the 12 months prior to screening. 8. Is not willing to adjust dosage of CBD-OS if needed when using strong inducers of CYP3A4 and/or strong inducers of CYP2C19 concomitantly with CBD-OS 9. Previously discontinued cannabidiol due to severe adverse events (SAE), hypersensitivity or lack of efficacy 10. Has clinically significant abnormal lab values 11. Has clinically impaired hepatic or renal function 12. History of, current risk or presence of actual suicidal ideations 13. Has any known or suspected hypersensitivity to cannabinoids or any of the excipients of CBD-OS, such as sesame oil. 14. Has a known or suspected history of alcohol or substance abuse disorder 15. Is currently consuming, and unwilling to stop consumption, or planning to consume tonic water on a regular basis throughout the study.

primary outcomes

primary measures

Percentage of participants reporting 50% or more reduction in their 28-day average countable major motor seizure frequency

Time frame: End of Treatment Period, Week 24

secondary outcomes

secondary measures

Retention Rate

Time frame: At Weeks 8, 12, 16 and 24

Retention Rate is defined as percentage of participants completing or continuing CBD-OS treatment at different timepoints in the study

Percentage of participants experiencing worsening, change, no change or improvement in in their 28-day average countable major motor and total seizure frequency

Time frame: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

As reported in participants' electronic diaries

Percentage of participants considered treatment responders

Time frame: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

Treatment responders will be categorized as those experiencing a 50% or more reduction, a 75% or more reduction or 100% reduction in their 28-day average seizure frequency as reported in participants' electronic diaries

Change in 28-day average frequency of countable major motor and total seizures

Time frame: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

Assessed per 28 days from electronic diary entries

Change in number of seizure-free days

Time frame: Baseline to Week 4, Baseline to Week 8, Baseline to Week 12, Baseline to Week 16, Baseline to Week 24

Assessed per 28 days from electronic diary entries

Change in CaGI-S severity of seizure scores

Time frame: Baseline to Week 16, Baseline to Week 24

Caregiver Global Impression of Severity (CaGI-S) is a single-item, 5-point Likert-type rating scale (ranging from 0 "not severe at all" to 5 "very severe"). Using this scale, caregivers will be asked to rate their impression of the participant's severity of seizures, and the severity of the impact caused by the seizure.

Change in CaGI-S severity of impact of seizures scores

Time frame: Baseline to Week 16, Baseline to Week 24

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 3bcdd95d-9532-40d4-b442-f2de9b394be5
Retrieved: 11/09/2026, 14:14:37
SHA-256: be256139e46c7234ee1aa821708759edda23e76b9b2a9f0ee799f512698d4495

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Cannabidiol Oral Solution

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Percentage of participants reporting 50% or more reduction in their 28-day average countable major motor seizure frequency

secondary measures

Retention Rate

Percentage of participants experiencing worsening, change, no change or improvement in in their 28-day average countable major motor and total seizure frequency

Percentage of participants considered treatment responders

Change in 28-day average frequency of countable major motor and total seizures

Change in number of seizure-free days

Change in CaGI-S severity of seizure scores

Change in CaGI-S severity of impact of seizures scores

Locally readable linked articles

Change in VAS scores

Change in CaGI-S severity of level of alertness scores

Change in CaGI-S severity of overall condition scores

CaGI-C level of alertness scores

CaGI-C overall condition scores

Change in CGI-S overall condition scores

CGI-C overall condition scores

Change in ELDQOL Behavior subscale scores

Change in ELDQOL seizure severity subscale scores

Change in ELDQOL mood scale subscale scores

Change in ELDQOL side-effects profile subscale scores

Number of participants reporting adverse events leading to discontinuation

Time the adverse events started from baseline

Number of Participants with Abnormal Laboratory Values

Change in suicidal ideation scores

Change in number of suicide attempts

Percentage of participants requiring inpatient hospitalization due to epilepsy

Change in number of usage of rescue medication