Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility 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.
- 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.