Tests rapamycin against placebo in hard-to-treat seizures from tuberous sclerosis
Tests rapamycin or a placebo in people with tuberous sclerosis and drug-resistant seizures.
Plain-language title generated from the registry record
Registry title: Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex
Key facts
- Where
- Lodz and Warsaw, PolandSee the 4 sites
- Phase
- Phase 3
Where in Poland
- Instytut Centrum Zdrowia Matki PolkiLodz, PolandTaking people
- Instytut Pomnik Centrum Zdrowia DzieckaWarsaw, PolandTaking people
- Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKPWarsaw, PolandTaking people
- Wojskowy Instytut Medycyny LotniczejWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Katarzyna Kotulska
- Trial code
- NCT05534672EU 2024-515937-13-00
- Record updated
- 22 October 2026
- Original description
The purpose of the RaRE-TS study is to determine safety, tolerability and efficacy of rapamycin versus placebo in a drug resistant epilepsy associated with tuberous sclerosis complex (TSC).Read full original descriptionShow less
Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With TSC
The purpose of the RaRE-TS study is to determine safety, tolerability and efficacy of rapamycin versus placebo in a drug resistant epilepsy associated with tuberous sclerosis complex (TSC).
Inclusion: male or female aged from 3 months up to 50 years at the day of randomization; patients/parents/caregivers are willing to and able to give informed consent form for the participation in the study; patients/parents/caregivers are willing to and able to comply with all study requirements; definite diagnosis of TSC according to the Consensus criteria (Northrup, 2013); drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks.
Exclusion: history of treatment with mTOR inhibitor in the three months prior to screening,; recent surgery within 2 weeks prior to the screening; severe infection within 2 weeks prior to the screening; history of pseudo-epileptic seizures,; history of progressive CNS disease other than TSC; use of the cannabis derivatives; contraindications for MRI or general anesthesia; occurrence of the serious comorbidities which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study the investigator; pregnancy.