A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

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.