Status: Recruiting
Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex
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).
Participants needed: 200
Trial details
Phase: Phase 3Age: 3-50Biological sex: AllType: InterventionalSponsor: Katarzyna KotulskaUpdated: Aug 8, 2023Locations: 2
Eligibility criteria
male or female aged from 3 months up to 50 years at the day of randomization [+4]
history of treatment with mTOR inhibitor in the three months prior to screening, [+8]