Phase 3 Epilepsy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 2 and 65 years old (inclusive), either male or female
• You have been diagnosed with Tuberous Sclerosis Complex (TSC) confirmed by a specialist through clinical assessment and/or genetic testing
• Your epilepsy is linked to TSC and has not been adequately controlled despite trying 2 or more anti-seizure medications, a ketogenic diet, a vagal nerve stimulator, and/or you are not a candidate for epilepsy surgery or still have seizures after surgery
• You have had at least 4 seizures with visible signs (such as loss of consciousness or movement) in the 4 weeks before starting the trial treatment
• Your anti-seizure medications and any other treatments (such as ketogenic diet or vagal nerve stimulator settings) have not changed for at least 4 weeks before starting the trial treatment
• You are currently taking 3 or fewer anti-seizure medications (note: Clobazam does not count toward this number for eligibility purposes)
• You (or your caregiver/family member, if you are a minor or under legal guardianship) are willing to keep a seizure diary throughout the trial
• If you are a woman who could become pregnant, you agree to use required contraceptive measures from signing the consent form until 3 months after stopping the trial medication
• You (or your legal representative) have signed the informed consent form

Who may not be able to join:

• You are currently taking corticosteroid (steroid) medication
• You are pregnant
• You are currently breastfeeding
• You have recently participated in another clinical trial and not enough time has passed since taking that trial's medication (at least 5 half-lives of the product, or 12 weeks if it contained cannabis oil)
• You have used a cannabis oil-based product in the last 12 weeks
• You did not take your anti-seizure medications as prescribed in the 4 weeks before the trial treatment was due to start
• You changed your anti-seizure medication, dose, ketogenic diet, or vagal nerve stimulator settings in the 4 weeks before the trial treatment was due to start
• You have significant heart, kidney, or liver failure, pancreatic problems, or certain blood abnormalities outside normal ranges (confirm with trial site for specific values)
• You have a serious uncontrolled medical condition such as liver disease, high bilirubin levels, cirrhosis, chronic hepatitis B or C, uncontrolled diabetes, active or uncontrolled serious infections, or active bleeding
• You or your caregiver/family member are unwilling or unlikely to follow the trial requirements and attend scheduled visits, in the opinion of your treating doctor
• You have a known allergy to any ingredient in the trial medication or placebo
• You or a first-degree blood relative (parent, sibling, or child) have a history of schizophrenia
• You have a personal history of suicide attempts

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