Trial intelligence / Profile preview

ViRap: Vigabatrin vs Rapamycin for Preventive Treatment in Infants With TSC

NCT04987463Phase 3Recruiting

Start
May 2021
Primary completion
Dec 2028
Modality
Small Molecules
Countries
1
01

Overview

Phase 3, randomised, double-blind trial in tuberous sclerosis complex (TSC) comparing Vigabatrin arm with Rapamycin arm (2 arms). Primary endpoints: Occurrence of clinical seizures at 730 days and Summarized volume of TSC-associated tumors >= 125% of initial value at 730 days. Started May 2021; status: recruiting.

02

Drugs

vigabatrinsirolimus
03

Conditions

tuberous sclerosis complex (TSC)

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