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Vigabatrin vs Rapamune for prevention of seizures and tumors in infants with tuberous sclerosis complex
2024-513068-25-00Phase 3Authorised
- Sponsor
- Children's Memorial Health Institute
- Start
- Dec 2024
- Modality
- Small Molecules
- Countries
- 1
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Overview
Phase 3, randomised, double-blind trial in tuberous sclerosis complex (TSC) and epilepsy comparing Vigabatrin (Sabril) arm with Rapamune (sirolimus) arm (2 arms). Primary endpoints: Occurrence of clinical seizures in the blinded phase of the study and Increase in summarized volume of TSC-associated tumors ≥ 25% of initial value within the blinded phase of the study. Planned start Dec 2024; status: authorised.
02
Drugs
vigabatrinsirolimus
03
Conditions
tuberous sclerosis complex (TSC)epilepsy
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