CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 200 target
Drug / intervention
Rapamycin +1 moreother
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Aged 3 months to 50 years at randomization
  • ✓Definite TSC diagnosis per Consensus criteria (Northrup 2013)
  • ✓Drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks
  • ✓Willing and able to provide informed consent
Key exclusion· 9
  • ✕mTOR inhibitor treatment in the 3 months prior to screening
  • ✕History of pseudo-epileptic seizures
  • ✕Progressive CNS disease other than TSC
  • ✕Surgery within 2 weeks prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05534672
NCT05534672Phase 3RecruitingOn TrackUpdated 34mo ago
Long Recruiting
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Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With TSC

Katarzyna Kotulska·interventional·Posted Sep 9, 2022·Updated Aug 8, 2023

In Brief

A Phase 3 clinical trial evaluating Rapamycin and Placebo for Tuberous Sclerosis Complex. Currently recruiting, targeting 200 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis Complex
CountriesPoland
Collaborators--

Timeline

Phase 3Recruiting
20232024202520262027
First PostedSep 9, 2022
Enrollment StartJan 23, 2023
Primary CompletionJun 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 3.8 years agoPrimary completion in 11 months

Interventions

Rapamycinother

Rapamycin in liquid administered orally

Placeboother

Placebo in liquid administered orally