Phase 3
N=171
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
Epilepsy · Lennox-Gastaut Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02224690 ↗Enrolled (actual)
171
Serious AEs
14.0%
Results posted
Jul 2018
Primary outcome: Primary: Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period — -43.90; -21.80 percentage change — p=0.0135
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GWP42003-P 20 mg/kg/day Dose (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period |
-43.90; -21.80 | 0.0135 sig |
| SECONDARY Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period |
38; 20 | 0.0043 sig |
| SECONDARY Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period |
-41.24; -13.70 | 0.0005 sig |
| SECONDARY Subject/Caregiver Global Impression Of Change Assessment (S/CGIC) |
15; 5; 14; 9; 20; 15 | 0.0012 sig |
Summary
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).
Eligibility Criteria
Key Inclusion Criteria
- Participant must have been male or female aged between 2 and 55 years (inclusive).
- Participant must have had a documented history of Lennox-Gastaut syndrome. 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.
- Participants had a history of slow ( 5 x upper limit of normal [ULN] or total bilirubin [TBL] >2 x ULN) OR the ALT or Aspartate aminotransferase (AST) >3 x ULN and (TBL >2 x ULN or international normalized ratio >1.5). This criterion can only be confirmed once the laboratory results are available; Participants randomized into the study who are later found not to meet this criterion should be withdrawn from the study.
- Any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale in the last month or at screening.
- Participant was taking more than 4 concurrent AEDs.
- Participant was taking corticotropins in the 6 months prior to screening.
- Participant was taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception was made of prophylactic medication, for example, idiopathic nephrotic syndrome or asthma.
- Participant was taking felbamate, and they had been taking it for less than 1 year prior to screening.
Data sourced from ClinicalTrials.gov (NCT02224690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.