A 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 (GWPCARE4)
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|ClinicalTrials.gov Identifier: NCT02224690|
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Lennox-Gastaut Syndrome||Drug: GWP42003-P Drug: Placebo Control||Phase 3|
This study is a 1:1 randomized, double-blind, 14-week comparison of GWP42003-P versus placebo. The treatment period will consist of a two-week titration period followed by a 12-week maintenance period. The study will aim to determine the efficacy, safety and tolerability of GWP42003-P compared with placebo. The dose will be as recommended by the Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data from Part A of study GWEP1332. The first subject will not enroll into this study until the DSMC has reviewed the safety data from Part A of study GWEP1332.
Following study completion, all subjects will be invited to continue to receive GWP42003-P in an open label extension (OLE) study (under a separate protocol).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||171 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||March 2015|
|Primary Completion Date :||February 2016|
|Study Completion Date :||June 2016|
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring).
GWP42003-P oral solution
Placebo Comparator: Placebo Control
Placebo oral solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Drug: Placebo Control
Placebo oral solution
Other Name: Placebo
- Percentage change from baseline in number of drop seizures (average per 28 days) during the treatment period. [ Time Frame: 0-14 weeks ]The primary endpoint is the percentage change from baseline in number of drop seizures (average per 28 days) during the treatment period (Day 1 to the end of the evaluable period) in subjects taking GWP42003-P compared with placebo. Non-parametric analyses will be used for the primary endpoint should the assumption for parametric analyses (e.g. Normality) not be valid.
- Percentage change from baseline in number of drop seizures (average per 28 days). [ Time Frame: 0-14 weeks ]
- Number of subjects considered treatment responders, defined as those with a ≥25%, ≥50%, ≥75%, or 100% reduction in drop seizures from baseline. [ Time Frame: 0-14 weeks ]
- Number of subjects experiencing a >25% worsening, −25 to +25% no change, 25-50% improvement, 50-75% improvement or >75% improvement in drop seizures from baseline. [ Time Frame: 0-14 weeks ]
- Percentage change from baseline in number of non-drop seizures (average per week). [ Time Frame: 0-14 weeks ]
- Percentage change from baseline in the frequencies of sub-types of seizures (average per week). [ Time Frame: 0-14 weeks ]
- Percent change from baseline in quality of life. [ Time Frame: 0-14 weeks ]
- Changes from baseline in the Caregiver Global Impression of Change (CGIC) score. [ Time Frame: End of week 14 of treatment ]
- The incidence of adverse events as measure of subject safety. [ Time Frame: Day -28 to Day 137 ]
- The number of age-appropriate subjects with a treatment-emergent flag using the Columbia-Suicide Severity Rating Scale (C-SSRS or C-SSRS Children's depending on age) during the course of the study. [ Time Frame: Day -28 to Day 137 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224690
|United States, Illinois|
|GW Investigational Site|
|Chicago, Illinois, United States|