A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Completed · Phase 3 · Has a placebo group
Conditions studied: Tuberous Sclerosis Complex, Seizures
In brief
This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.
Key facts
- Study ID
- NCT02544763
- Run by
- Jazz Pharmaceuticals
- People needed
- 224
- Starts
- 2016-04-06
- Expected to finish
- 2019-02-26
- Last updated by the study team
- 2022-09-28
Who can join
Age: 1 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- 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
Full record on ClinicalTrials.gov
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