Phase 3
N=120
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
Epilepsy · Dravet Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02091375 ↗Enrolled (actual)
120
Serious AEs
10.8%
Results posted
Jul 2018
Primary outcome: Primary: Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period — -38.94; -13.29 percent change — p=0.0123
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GWP42003-P 20 mg/kg/day Dose (Drug); Placebo control (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Jazz Pharmaceuticals
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period |
-38.94; -13.29 | 0.0123 sig |
| SECONDARY Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period |
26; 16 | 0.0784 |
| SECONDARY Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period |
38; 26; 14; 7; 3; 0 | — |
| SECONDARY Percentage Change From Baseline In Non-Convulsive Seizure Frequency During The Treatment Period |
-40.16; -34.69 | — |
| SECONDARY Caregiver Global Impression Of Change In Seizure Duration (CGICSD) |
17; 8; 32; 31; 0; 2 | — |
| SECONDARY Number Of Participants Using Rescue Medication |
36; 41 | — |
| SECONDARY Number Of Participants With Inpatient Hospitalizations Due To Epilepsy |
5; 1; 2; 1 | — |
| SECONDARY Change From Baseline In Sleep Disruption 0 To 10 Numerical Rating Scale (0 to 10 NRS) Score |
-0.7; -0.3 | — |
| SECONDARY Change From Baseline In Epworth Sleepiness Scale (ESS) Score |
0.82; -0.69 | — |
| SECONDARY Change From Baseline In Quality Of Life In Childhood Epilepsy (QOLCE) Score |
5.6; 4.1 | — |
| SECONDARY Change From Baseline In Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score |
-0.8; 3.0; -0.8; -0.8; -0.6; -0.6 | — |
| SECONDARY Caregiver Global Impression Of Change (CGIC) |
9; 4; 10; 4; 18; 12 | — |
Summary
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
Eligibility Criteria
Key Inclusion Criteria
- Participants were male or female aged between 2 and 18 years (inclusive).
- Participants had a documented history of Dravet Syndrome that was not completely controlled by current antiepileptic drugs.
- Participants took one or more antiepileptic drugs at a dose that had been stable for at least four weeks.
- All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) were stable for four weeks prior to screening and participants were willing to maintain a stable regimen throughout the study.
Key Exclusion Criteria
- Participants had clinically significant unstable medical conditions other than epilepsy.
- Participants had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization, other than epilepsy.
- Participants were currently using or had in the past used recreational or medicinal cannabis or synthetic cannabinoid based medications (including Sativex®) within the three months prior to study entry and were unwilling to abstain for the duration for the study.
- Participants had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
- Participants had been part of a previous clinical trial involving another investigational product in the previous six months.
- There were plans for the participants to travel outside their country of residence during the study.
- Participants previously randomized into this study. In particular, participants who participated in Part A of the study could not enter Part B.
Data sourced from ClinicalTrials.gov (NCT02091375). 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.