Phase 3 Epilepsy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You (or your child) must be between 3 months and 50 years old at the time of joining the trial
- You (or your child's parent/caregiver) must be willing and able to give written agreement to take part in the study
- You (or your child's parent/caregiver) must be willing and able to follow all of the study's requirements
- You (or your child) must have a confirmed diagnosis of Tuberous Sclerosis Complex (TSC) based on recognised diagnostic guidelines
- You (or your child) must have epilepsy related to TSC that has not been controlled by medication, with at least 8 seizures over a 4-week period
Who may not be able to join:
- You (or your child) have been treated with a type of drug called an mTOR inhibitor in the three months before screening
- You (or your child) have a history of seizures that are not caused by epilepsy (sometimes called non-epileptic or psychological seizures)
- You (or your child) have a history of another progressive brain or nervous system condition other than TSC
- You (or your child) have had surgery within 2 weeks before the screening visit
- You (or your child) have had a serious infection within 2 weeks before the screening visit
- You (or your child) currently use cannabis or cannabis-based products
- You (or your child) have any reason why an MRI scan or general anaesthetic would not be safe for them
- You (or your child) have other serious health conditions that the trial doctor believes could put you at risk or affect the trial results (confirm with trial site)
- You are currently pregnant
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: +48 22 8157404
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
comparison of the number of patients with at least 50% reduction of seizures per week in the last month of the core blinded phase in comparison to screening phase in the rapamycin vs placebo group; number of adverse events (according to CTCAE classification) in the rapamycin vs placebo group during the double-blind core phase
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.