NCT02544763

Who might be able to join this trial:

• You have a well-documented medical history of epilepsy (seizures).
• You have been diagnosed with Tuberous Sclerosis Complex (TSC) based on the internationally agreed 2012 diagnostic guidelines.
• Any medications or treatments you are currently using for epilepsy (including a ketogenic diet or nerve stimulation devices) have not changed in the last month before screening, and you are willing to keep them the same throughout the trial.

Who may not be able to join:

• You have a history of "pseudo-seizures" (seizures that are not caused by abnormal electrical activity in the brain) (confirm with trial site).
• You have other serious or unstable medical conditions besides epilepsy.
• You had an illness other than epilepsy in the 4 weeks before screening that could affect how often you have seizures, in the opinion of the doctor running the trial.
• You had a general anaesthetic (were put fully to sleep for a procedure) in the 4 weeks before screening or the start of the trial.
• You had surgery for epilepsy in the 6 months before screening.
• You are being considered for epilepsy surgery or any procedure that would require a general anaesthetic.
• You have been taking a medication called felbamate for less than 1 year before screening.
• You are currently taking a type of oral medication known as an mTOR inhibitor (confirm with trial site).
• You have a known or suspected allergy or sensitivity to cannabinoids (cannabis-related compounds) or any ingredient in the trial medication, such as sesame oil.
• You have a history of suicidal behaviour, or have had certain levels of suicidal thoughts (type 4 or 5 on a specific medical scale) in the last month or at the time of screening.
• You are currently using, or have used in the past 3 months, recreational or medicinal cannabis or any cannabis-based medications, and are unwilling to stop for the duration of the trial.
• You have tumour growth that, in the opinion of the trial doctor, could affect the trial's results.
• Your liver is not functioning well enough at the time of screening or the start of the trial.
• You have taken part in another clinical trial and received an experimental medication within the 12 weeks before screening.

Important: Always verify eligibility with the trial site directly before applying.