A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Condition: Tuberous Sclerosis Complex; Seizures
MeSH terms: Tuberous Sclerosis; Seizures; Sclerosis
Intervention: GWP42003-P; Placebo
Intervention description: Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.; Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 1 Year
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.