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NCT05104983 · ClinicalTrials.gov registry record · Phase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
A Phase 2 study of Epilepsy and Tuberous Sclerosis Complex, sponsored by Darcy Krueger.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 11
- Study locations
NCT05104983 is a Phase 2 study of Epilepsy and Tuberous Sclerosis Complex that is actively recruiting participants, run by Darcy Krueger. The registered enrollment target is 64 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (93% lower). The trial reports 11 study locations across 10 states.
The verdict
NCT05104983, a Phase 2 study of Epilepsy and Tuberous Sclerosis Complex, is actively recruiting participants, sponsored by Darcy Krueger.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 11
- Study locations
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 Studied
Interventions
- DRUG Sirolimus
- DRUG Placebo
Study Locations (11)
California
- University of California at Los Angeles - Los Angeles
- Stanford University - Palo Alto
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
Illinois
- Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Missouri
- Washington University -- St. Louis - St Louis
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-10-13 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05104983
The ClinicalTrials.gov registry entry for NCT05104983 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (93% lower). The listed sponsor is Darcy Krueger, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Sirolimus is the first listed.
NCT05104983 reports 11 study locations spanning 10 distinct geographic areas - top geographies include California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT05104983 about?
NCT05104983 is a clinical study titled "Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study". 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 Fo...
What is the current status of trial NCT05104983?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2021-10-13. Estimated completion is 2027-06-30.
What conditions does trial NCT05104983 study?
This clinical trial studies the following conditions: Epilepsy, Tuberous Sclerosis Complex.
What interventions are being tested in trial NCT05104983?
The interventions under investigation include: Sirolimus (DRUG), Placebo (DRUG).
Who is sponsoring clinical trial NCT05104983?
This trial is sponsored by Darcy Krueger, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05104983 being conducted?
This trial has 11 study locations across Alabama, California, Colorado, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.