A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 1 - 65 |
| Updated: | 9/28/2018 |
| Start Date: | April 2016 |
| End Date: | February 2019 |
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
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.
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.
Key Inclusion Criteria:
- Participant has a well-documented clinical history of epilepsy.
- Participant has a clinical diagnosis of Tuberous Sclerosis Complex (TSC) according to
the criteria agreed by the 2012 International TSC Consensus Conference.
- All medications or interventions for epilepsy (including ketogenic diet and any
neurostimulation devices for epilepsy) must have been stable for 1 month prior to
screening and the participant is willing to maintain a stable regimen throughout the
trial.
Key Exclusion Criteria:
- Participant has a history of pseudo-seizures.
- Participant has clinically significant unstable medical conditions other than
epilepsy.
- Participant has an illness in the 4 weeks prior to screening or randomization, other
than epilepsy, which in the opinion of the investigator could affect seizure
frequency.
- Participant has undergone general anesthetic in the 4 weeks prior to screening or
randomization.
- Participant has undergone surgery for epilepsy in the 6 months prior to screening.
- Participant is being considered for epilepsy surgery or any procedure involving
general anesthesia.
- Participant has been taking felbamate for less than 1 year prior to screening.
- Participant is taking an oral mTOR inhibitor.
- Participant has any known or suspected hypersensitivity to cannabinoids or any of the
excipients of the Investigational Medicinal Product (IMP), such as sesame oil.
- Participant has any history of suicidal behavior or any suicidal ideation of type 4 or
5 on the C-SSRS in the last month or at screening.
- Participant is currently using or has in the past used recreational or medicinal
cannabis, or cannabinoid-based medications, within the 3 months prior to screening and
is unwilling to abstain for the duration for the study.
- Participant has tumor growth which, in the opinion of the Investigator, could affect
the primary endpoint.
- Participant has significantly impaired hepatic function at the screening or
randomization visit
- Participant has received an IMP within the 12 weeks prior to the screening visit.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: +44 (0) 1223 266 800
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