GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
NCT ID: NCT02224703
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
199 participants
INTERVENTIONAL
2015-04-13
2018-04-09
Brief Summary
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Detailed Description
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Following study completion, all participants were invited to continue to receive GWP42003-P in a separate open-label extension study (GWEP1415; NCT02224573).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10 mg/kg/day GWP42003-P
GWP42003-P oral solution (100 mg/milliliter \[mL\] cannabidiol in sesame oil with anhydrous ethanol with added sweetener \[sucralose\] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 20 mg/kg/day dose.
GWP42003-P
20 mg/kg/day GWP42003-P
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener \[sucralose\] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
GWP42003-P
Placebo Control
Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
Placebo Control
Interventions
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GWP42003-P
Placebo Control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Sacramento, California, United States
Hartford, Connecticut, United States
Miami, Florida, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Buffalo, New York, United States
Chapel Hill, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Heidelberg, , Australia
Randwick, , Australia
Ramat Gan, , Israel
Heeze, , Netherlands
Zwolle, , Netherlands
Krakow, , Poland
Lodz, , Poland
Warsaw, , Poland
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Pamplona, , Spain
Seville, , Spain
Valencia, , Spain
Countries
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References
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Madan Cohen J, Checketts D, Dunayevich E, Gunning B, Hyslop A, Madhavan D, Villanueva V, Zolnowska M, Zuberi SM. Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials. Epilepsia. 2021 Sep;62(9):2218-2227. doi: 10.1111/epi.16974. Epub 2021 Jul 15.
Miller I, Scheffer IE, Gunning B, Sanchez-Carpintero R, Gil-Nagel A, Perry MS, Saneto RP, Checketts D, Dunayevich E, Knappertz V; GWPCARE2 Study Group. Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet Syndrome: A Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):613-621. doi: 10.1001/jamaneurol.2020.0073.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-002939-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GWEP1424
Identifier Type: -
Identifier Source: org_study_id
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