Clinical Trials

Inclusion Criteria:

• Participant has a well-documented history of epilepsy, with compatible electroencephalogram (EEG) and clinical history.
• 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.

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 is taking felbamate, and they have been taking it 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 had active suicidal plan/intent in the past 6 months, or has a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
• Participant has C-SSRS grade 4 or 5 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.