Status:
COMPLETED
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Epilepsy
Dravet Syndrome
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
Detailed Description
This study was a 2:2:1:1 randomized, double-blind, 14-week comparison of two dose levels of GWP42003-P (10 milligram/kilogram \[mg/kg\]/day and 20 mg/kg/day) versus placebo (10 mg/kg/day dose-volume e...
Eligibility Criteria
Inclusion
- Key
- Participant must have been male or female, aged between 2 and 18 years (inclusive).
- Participant must have had a documented history of Dravet syndrome that was not completely controlled by current antiepileptic drugs.
- Participant must have been taking 1 or more antiepileptic drugs at a dose that had been stable for at least 4 weeks.
- All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation) must have been stable for 4 weeks prior to screening and participant was willing to maintain a stable regimen throughout the study.
- Key
Exclusion
- 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.
- Participant was currently using or had in the past used recreational cannabis, medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to study entry and was unwilling to abstain for the duration for the study.
- Participant had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
- There were plans for the participant to travel outside their country of residence during the study.
- Any history of suicidal behavior or any suicidal ideation of type four or five on the Columbia-Suicide Severity Rating Scale (Children's) at screening.
Key Trial Info
Start Date :
April 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT02224703
Start Date
April 13 2015
End Date
April 9 2018
Last Update
September 28 2022
Active Locations (38)
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1
Birmingham, Alabama, United States, 35233
2
Little Rock, Arkansas, United States, 72202
3
Los Angeles, California, United States, 90027
4
Sacramento, California, United States, 95816