OncoMatch/Clinical Trials/NCT05104983
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Is NCT05104983 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sirolimus for tuberous sclerosis complex.
Treatment: Sirolimus — 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).
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: anticonvulsant
Has been treated in the past or is currently being treated at the time of enrollment with conventional anticonvulsant medications (AEDs)
Cannot have received: mTOR inhibitor (rapamycin, sirolimus, everolimus)
systemic (oral) mTOR inhibitors (such as rapamycin, sirolimus, or everolimus)
Cannot have received: ketogenic-related special diet
ketogenic-related special diet
Cannot have received: anti-seizure therapeutic agent, device, or procedure
another anti-seizure therapeutic agent, device, or procedure
Cannot have received: investigational drug
Has taken any other investigational drug as part of another research study, within 30 days prior to the baseline screening visit
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- University of California at Los Angeles · Los Angeles, California
- Stanford University · Palo Alto, California
- Children's Hospital Colorado · Aurora, Colorado
- Lurie Children's Hospital of Chicago · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
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