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Phase 2Recruiting

Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study (TSC-STEPS)

Sponsor
Darcy Krueger (Academic or other)
Enrolment
64 planned
Conditions
Tuberous Sclerosis Complex; Epilepsy
Interventions
Sirolimus; Placebo
Ages
children
Registry
NCT05104983

Full record on ClinicalTrials.gov

From the registry

This trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants. This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).

Primary outcomes

  • Efficacy -- time to seizure onset
  • Safety -- adverse events

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Registered

  5. Started