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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: Recruiting Phase 2 study of Epilepsy and Tuberous Sclerosis Complex, sponsored by Darcy Krueger.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Time to seizure onset, comparing sirolimus with placebo
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 |
What NCT05104983 shows while recruiting
NCT05104983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (93% lower).
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 lists 11 locations in 10 states (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.
Learn More About Clinical Trials
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Where NCT05104983's enrollment target sits among peer trials
64 76th of 160 higher than 84 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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