NCT02544763 - A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) | Biotech Hunter

Enrollment

224

Participants

Timeline

Start Date

April 6, 2016

Primary Completion Date

January 22, 2019

Study Completion Date

February 26, 2019

Conditions

Tuberous Sclerosis ComplexSeizures

Interventions

DRUG

GWP42003-P

Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.

DRUG

Placebo

Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.

Trial Locations (44)

10016

NYU Comprehensive Epilepsy Center, New York

17345

WellSpan Paediatric Neurology, Manchester

20817

Mid Atlantic Epilepsy & Sleep Centre, Bethesda

22903

University of Virginia, Charlottesville

27157

Wake Forest Baptist Medical Center, Winston-Salem

27599

University of North Carolina at Chapel Hill, Chapel Hill

33155

Pediatric Neurology, Miami

35294

UAB Epilepsy Center, Birmingham

38103

Le Bonheur Children's Hospital, Memphis

55102

Minnesota Epilepsy Group, P.A, Saint Paul

55905

Mayo Clinic, Rochester

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

72202

Arkansas Children's Hospital, Little Rock

75104

Texas Scottish Rite Hospital for Children, Dallas

76104

Cook Children's Health Care System, Fort Worth

80045

University of Colorado Denver, Aurora

84113

Paediatric Neurology, Salt Lake City

90095

UCLA-Pediatric Neurology, Los Angeles

94609

UCSF Benioff Children's Hospital Oakland, Oakland

97239

Oregon Health & Science University, Portland

98105

Seattle Children's Hospital, Seattle

02114

Massachusetts General Hospital, Boston

Unknown

Austin Health, Heidelberg

Royal Brisbane and Women's Hospital, Herston

The Royal Melbourne Hospital, Parkville

Sydney Children's Hospital, Randwick

Erasmus MC/Sophia Children's Hospital, Rotterdam

UMC Utrecht/ Wilhelmina, Kinderziekenhuis, Utrecht

Vitamed Gałaj I Cichomski Spółka Jawna, Bydgoszcz

Centrum Medyczne Plejady, Krakow

Wojewódzki Szpital Specjalistyczny im S. K. Wyszyńskiego SPZOZ, Lublin

"Instytut Pomnik - Centrum Zdrowia Dziecka", Warsaw

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego w Warszawie, Warsaw

"Centrum Neuropsychiatrii Neuromed", Wroclaw

Centro Médico Teknon, Barcelona

Clinical Research Unit, Barcelona

Unitat d'Epilèpsia, Barcelona

Hospital Infantil Universitario Niño Jesús, Madrid

Clinica Universidad de Navarra, Pamplona

Cardiff and Vale University Local Health Board, Cardiff

Children and Young Adults' Research Unit, Cardiff

NIHR Clinical Research Facility, London

St George's University Hospitals NHS Foundation Trust, London