Clinical trialNCT05104983RecruitingPhase 2Interventional

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

SponsorDarcy KruegerEnrollment64EpilepsyTuberous Sclerosis Complex

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Darcy A Krueger, MD, PhD
Children's Hospital Medical Center, Cincinnati
Principal Investigator
clinicaltrials.gov ↗
Martina Bebin, MD, MPA
University of Alabama at Birmingham
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
E. Martina Bebin, MD, MPA
Recruiting
University of California at Los Angeles
Los Angeles, California, United States
Rajsekar Rajamaran, MD, MS
Recruiting
Stanford University
Palo Alto, California, United States
Brenda Porter, MD
Recruiting
Children'S Hospital Colorado
Aurora, Colorado, United States
Kevin Ess, MD
Recruiting
Lurie Children'S Hospital of Chicago
Chicago, Illinois, United States
Tracy Gertler, MD
Recruiting
Boston Children'S Hospital
Boston, Massachusetts, United States
Mustafa Sahin, MD, PhD
Recruiting
Washington University -- St. Louis
St Louis, Missouri, United States
Michael Wong, MD, PhD
Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Active, not recruiting
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Darcy A Krueger, MD, PhD
Recruiting
University of Texas Hsc at Houston
Houston, Texas, United States
Hope Northrup, MD
Recruiting
Seattle Children'S Hospital
Seattle, Washington, United States
Stephanie Randle, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboSirolimus →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 13 Oct 2021
Primary completion: 30 Jun 2026
Completion: 30 Jun 2027
Last update posted: 22 Jan 2026
Registered enrollment: 64
Registry id: NCT05104983

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.