NCT02544750

An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberous Sclerosis Complex
• Seizures

Interventions

Type	Name	Description
DRUG	GWP42003-P	Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.

Timeline

• Start date: 2016-08-31
• Primary completion: 2021-06-11
• Completion: 2021-06-11
• First posted: 2015-09-09
• Last updated: 2022-07-14
• Results posted: 2022-07-14

Locations

1 site across 1 country: United States