Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex — RaRE-TS  

Tuberous Sclerosis Complex Clinical Trial

Official title: Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With TSC

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial Description

This is a two-arm, randomized, double-blind, placebo controlled study to evaluate the efficacy, tolerability, and safety of rapamycin versus placebo in a drug resistant epilepsy associated with TSC. The study consists of 3 phases for each patient: screening, dose adjustment blinded phase, core blinded phase, followed by open-label observation. Patients who meet the eligibility criteria will be randomized to receive rapamycin or placebo. The randomization ratio is 1:1. Randomization will be stratified by age, sex and and the number of antiepileptic drugs ever used in the patient's history (up to 3 drugs / more than 3 drugs). ;

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Sclerosis
• Tuberous Sclerosis
• Tuberous Sclerosis Complex

• NCT number: NCT05534672
• Study type: Interventional
• Source: Children's Memorial Health Institute, Poland
• Contact: Katarzyna Kotulska-Jozwiak
• Phone: +48 22 8157404
• Email: k.kotulska@ipczd.pl
• Status: Recruiting
• Phase: Phase 3
• Start date: January 23, 2023
• Completion date: June 2027