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Study details
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Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study

Darcy Krueger
NCT IDNCT05104983ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

64

Study length

about 5.7 years

Ages

0.00273790700698851–0.5

Locations

11 sites in AL, CA, CO +7

What this study is about

Researchers are testing sirolimus to prevent or delay seizures in children with Tuberous Sclerosis Complex (TSC). The trial will last for about two years. Participants will be randomly assigned to receive either a placebo or sirolimus.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Placebo
  • 2.Take Sirolimus

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

sirolimus

Drug routes

injection, intravenous

Endpoints

Primary: Safety -- adverse events

Secondary: MRI Biomarkers, Quality of Life Outcomes

Body systems

Neurology