103
Participants
Start Date
May 31, 2021
Primary Completion Date
December 21, 2023
Study Completion Date
December 21, 2023
GWP42003-P
GWP42003-P oral solution (100 milligrams per milliliter \[mg/mL\] cannabidiol \[CBD\] in sesame oil with anhydrous ethanol, ethanol \[10% v/v\] sweetener \[sucralose\], and strawberry flavoring), administered twice a day (morning and evening)
Placebo
Oral placebo to match GWP42003-P oral solution containing sesame oil with anhydrous ethanol, sweetener (sucralose), strawberry flavoring, and beta carotene, administered twice a day (morning and evening)
Queensland Children's Hospital, South Brisbane
Richmond Behavioral Associates, Staten Island
Children's Hospital of Philadelphia, Philadelphia
APG Research, LLC, Orlando
University of Louisville, Louisville
Zentralinstitut fuer Seelische Gesundheit, Mannheim
Red Oak Psychiatry Associates, PA, Houston
Klinik fur Psychiatrie, Psychotherapie und Psychosomatik im Kindes und Jugendalter, Freiburg im Breisgau
Southwest Autism Research and Resource Center (SARRRC), Phoenix
UCLA Neuropsychiatric Institute, Los Angeles
UCSD School of Medicine, La Jolla
University of California San Francisco, San Francisco
Seattle Children's Research Institute, Seattle
Boston Children's Hospital, Boston
Massachusetts General Hospital (Lurie Center for Autism), Lexington
Monash Medical Centre, Clayton
The Kids Clinic, Ajax
Center for Pediatric Excellence, Ottawa
Instituto Global de Atencion Integral del Neurodesarrollo (IGAIN), Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
Corporacio Sanitaria Parc Tauli, Sabadell
University of Glasgow Institute of Health and Wellbeing, Glasgow
Institute of Psychiatry, King's College London, London
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY