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NCT04595513 · ClinicalTrials.gov registry record · Phase 1
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04595513: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04595513 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04595513, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).
Primary Outcome
Percentage of subjects reporting severe (CTCAE v5.0 grade \>= 3) adverse event (AE) or serious adverse event (SAE)
Interventions
- DRUG TAVT-18 (sirolimus)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-09-08 |
| Est. Completion | 2022-12-15 |
| Phase | Phase 1 |
What the finished NCT04595513 record still lists
NCT04595513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which TAVT-18 (sirolimus) is the first listed.
NCT04595513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04595513 about?
NCT04595513 is a clinical study titled "Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants". This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).
What is the current status of trial NCT04595513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-09-08. Estimated completion is 2022-12-15.
What interventions are being tested in trial NCT04595513?
The interventions under investigation include: TAVT-18 (sirolimus) (DRUG).
Who is sponsoring clinical trial NCT04595513?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04595513's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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