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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02544763

Public ClinicalTrials.gov record NCT02544763. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 6:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02544763
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
224 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Year to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 6, 2016 (Actual)
Primary completion
Jan 22, 2019 (Actual)
Completion
Feb 26, 2019 (Actual)
Last update posted
Sep 28, 2022

2016 – 2019

United States locations

U.S. sites
23
U.S. states
19
U.S. cities
23
Facility City State ZIP Site status
UAB Epilepsy Center Birmingham Alabama 35294 —
Arkansas Children's Hospital Little Rock Arkansas 72202 —
UCLA-Pediatric Neurology Los Angeles California 90095 —
UCSF Benioff Children's Hospital Oakland Oakland California 94609 —
University of Colorado Denver Aurora Colorado 80045 —
Pediatric Neurology Miami Florida 33155 —
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Mid Atlantic Epilepsy & Sleep Centre Bethesda Maryland 20817 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Mayo Clinic Rochester Minnesota 55905 —
Minnesota Epilepsy Group, P.A Saint Paul Minnesota 55102 —
Washington University School of Medicine St Louis Missouri 63110 —
NYU Comprehensive Epilepsy Center New York New York 10016 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 —
Oregon Health & Science University Portland Oregon 97239 —
WellSpan Paediatric Neurology Manchester Pennsylvania 17345 —
Le Bonheur Children's Hospital Memphis Tennessee 38103 —
Texas Scottish Rite Hospital for Children Dallas Texas 75104 —
Cook Children's Health Care System Fort Worth Texas 76104 —
Paediatric Neurology Salt Lake City Utah 84113 —
University of Virginia Charlottesville Virginia 22903 —
Seattle Children's Hospital Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02544763, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2022 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02544763 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →