drugset / Trial / NCT04987463

Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants

NCT04987463

Phase 2/3 Unknown 60 enrolled Katarzyna Kotulska
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of the study is to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with Tuberous Sclerosis Complex (TSC).

Timeline

Start
2021-05-07
Primary completion
2026-03
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule Oral
Subject Vigabatrin Small molecule Oral

Indications