A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
NCT ID: NCT02544763
Last Updated: 2022-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
224 participants
INTERVENTIONAL
2016-04-06
2019-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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25 mg/kg/day GWP42003-P
100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening).
GWP42003-P
Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
50 mg/kg/day GWP42003-P
100 mg/mL GWP42003-P oral solution taken twice daily (morning and evening).
GWP42003-P
Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Placebo
Placebo oral solution matching 100 mg/mL GWP42003-P.
Placebo
Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Interventions
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GWP42003-P
Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Placebo
Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has a clinical diagnosis of Tuberous Sclerosis Complex (TSC) according to the criteria agreed by the 2012 International TSC Consensus Conference.
* All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for 1 month prior to screening and the participant is willing to maintain a stable regimen throughout the trial.
Exclusion Criteria
* Participant has clinically significant unstable medical conditions other than epilepsy.
* Participant has an illness in the 4 weeks prior to screening or randomization, other than epilepsy, which in the opinion of the investigator could affect seizure frequency.
* Participant has undergone general anesthetic in the 4 weeks prior to screening or randomization.
* Participant has undergone surgery for epilepsy in the 6 months prior to screening.
* Participant is being considered for epilepsy surgery or any procedure involving general anesthesia.
* Participant has been taking felbamate for less than 1 year prior to screening.
* Participant is taking an oral mTOR inhibitor.
* Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), such as sesame oil.
* Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at screening.
* Participant is currently using or has in the past used recreational or medicinal cannabis, or cannabinoid-based medications, within the 3 months prior to screening and is unwilling to abstain for the duration for the study.
* Participant has tumor growth which, in the opinion of the Investigator, could affect the primary endpoint.
* Participant has significantly impaired hepatic function at the screening or randomization visit
* Participant has received an IMP within the 12 weeks prior to the screening visit.
1 Year
65 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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UAB Epilepsy Center
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UCLA-Pediatric Neurology
Los Angeles, California, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Pediatric Neurology
Miami, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Mid Atlantic Epilepsy & Sleep Centre
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Minnesota Epilepsy Group, P.A
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
NYU Comprehensive Epilepsy Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
WellSpan Paediatric Neurology
Manchester, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Texas Scottish Rite Hospital for Children
Dallas, Texas, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
Paediatric Neurology
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Austin Health
Heidelberg, , Australia
Royal Brisbane and Women's Hospital
Herston, , Australia
The Royal Melbourne Hospital
Parkville, , Australia
Sydney Children's Hospital
Randwick, , Australia
Erasmus MC/Sophia Children's Hospital
Rotterdam, , Netherlands
UMC Utrecht/ Wilhelmina, Kinderziekenhuis
Utrecht, , Netherlands
Vitamed Gałaj I Cichomski Spółka Jawna
Bydgoszcz, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Wojewódzki Szpital Specjalistyczny im S. K. Wyszyńskiego SPZOZ
Lublin, , Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, , Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego w Warszawie
Warsaw, , Poland
Centrum Neuropsychiatrii "Neuromed"
Wroclaw, , Poland
Centro Médico Teknon
Barcelona, , Spain
Clinical Research Unit
Barcelona, , Spain
Unitat d'Epilèpsia
Barcelona, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Cardiff and Vale University Local Health Board
Cardiff, , United Kingdom
Children and Young Adults' Research Unit
Cardiff, , United Kingdom
NIHR Clinical Research Facility
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Burke C, Crossan C, Tyas E, Hemstock M, Lee D, Bowditch S. A Cost-Utility Analysis of Add-On Cannabidiol Versus Usual Care Alone for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in England and Wales. Pharmacoecon Open. 2024 Jul;8(4):611-626. doi: 10.1007/s41669-024-00474-x. Epub 2024 Mar 5.
Wu JY, Cock HR, Devinsky O, Joshi C, Miller I, Roberts CM, Sanchez-Carpintero R, Checketts D, Sahebkar F. Time to onset of cannabidiol treatment effect and resolution of adverse events in tuberous sclerosis complex: Post hoc analysis of randomized controlled phase 3 trial GWPCARE6. Epilepsia. 2022 May;63(5):1189-1199. doi: 10.1111/epi.17199. Epub 2022 Mar 4.
Thiele EA, Bebin EM, Filloux F, Kwan P, Loftus R, Sahebkar F, Sparagana S, Wheless J. Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial. Epilepsia. 2022 Feb;63(2):426-439. doi: 10.1111/epi.17150. Epub 2021 Dec 27.
Thiele EA, Bebin EM, Bhathal H, Jansen FE, Kotulska K, Lawson JA, O'Callaghan FJ, Wong M, Sahebkar F, Checketts D, Knappertz V; GWPCARE6 Study Group. Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex: A Placebo-Controlled Randomized Clinical Trial. JAMA Neurol. 2021 Mar 1;78(3):285-292. doi: 10.1001/jamaneurol.2020.4607.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-002154-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GWEP1521 Blinded Phase
Identifier Type: -
Identifier Source: org_study_id
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