CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 199 enrolled
Drug / intervention
GWP42003-Pdrug
Likely dose
Cannabidiol (GWP42003-P) — yellow oily solution containing cannabidiol dissolved in sesame oil and anhydrous ethanolAI-extracted
Key inclusion· 1
  • ✓Completion of the GWEP1521 Blinded Phase
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02544750
NCT02544750Phase 3Completed
CompareCT.gov

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

Jazz Pharmaceuticals·interventional·Posted Sep 9, 2015·Updated Jul 14, 2022

In Brief

A Phase 3 clinical trial evaluating GWP42003-P for Tuberous Sclerosis Complex and Seizures. Completed, enrolled 199 participants across 1 site.

Detailed Summary

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis Complex, Seizures
CountriesUnited States
CollaboratorsGW Pharmaceuticals Ltd

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 9, 2015
Enrollment StartAug 31, 2016
Primary CompletionJun 11, 2021
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.8 years ago

Interventions

GWP42003-Pdrug

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