Clin2
NCT05104983Possibly a fitRecruiting

Sirolimus to prevent first seizures in babies with TSC

Tuberous Sclerosis ComplexEpilepsy

Treatments studied

Part of Brain & nervous system, Cancer, Genetic & congenital clinical trials.

This Phase 2 study tests whether sirolimus (a targeted medicine) can stop or slow the start of seizures in very young babies diagnosed with tuberous sclerosis complex (TSC). If seizures are prevented early, it may also help protect early brain development.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
64 people
Ages
1 day to 6 months
Study type
Interventional

Who can take part

  • Baby must be under 7 months old when starting the study (born at least 39 weeks corrected age).
  • Baby must have a confirmed TSC diagnosis (from clinical exam or genetic testing).
  • Baby must not have had seizures yet, including on a baseline EEG test.
  • Baby must not be taking anti-seizure medicines, sirolimus/other mTOR medicines, or special seizure diets right now.
  • Baby must not have had certain procedures or major birth complications that greatly raise seizure/development risk.
  • Baby must not have needed mTOR treatment for specific TSC problems (like SEGA or AML).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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