MedTrace Logo

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

NCT05104983 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-01-22

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Sirolimus

The investigational drug product to be used in this study is sirolimus, provided in oral suspension.

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • Darcy Krueger

    lead OTHER

Principal Investigators

  • Darcy A Krueger, MD, PhD · Children's Hospital Medical Center, Cincinnati

  • Martina Bebin, MD, MPA · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05104983 on ClinicalTrials.gov