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 NCT02544763
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 NCT02544763
How long is the study? Study length: 5 weeks of baseline and 16 weeks of treatment followed by a one- year Open Label Extension.
Who is eligible?
Participants must have a well-documented history of epilepsy as well as a TSC diagnosis confirmed by clinical exam or genetic testing consistent with the criteria set forth in the 2012 International TSC Consensus Conference. All medications or interventions for epilepsy must be stable for one month prior to the trial.
Participants must not be taking oral mTOR inhibitors. Participants must not be currently using or have in the past 3 months prior to screening used recreational or medicinal cannabis, or cannabinoid-based medications. Participants must be willing to abstain from any cannabis exposure for the duration for the study.
Note: Participants will be randomly assigned to either placebo or active treatment groups (added to their existing medications). All patients who complete the trial will be invited to participate in the open label extension, where all receive active treatment.
The trial is taking place in sites in Cardiff and London, a number of which are willing to consider referrals from clinicians in other areas.
If you would like more information, please email firstname.lastname@example.org or call 01233 238 170.