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NCT03589976 · ClinicalTrials.gov registry record · Phase 2
A Futility Trial of Sirolimus in Multiple System Atrophy
A Phase 2 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT03589976 is a Phase 2 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 47 participants.
The verdict
NCT03589976, a Phase 2 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
Single-center, randomized, placebo-controlled, phase-II, futility clinical trial to determine if oral sirolimus is of sufficient promise to slow disease progression in MSA, prior to embarking on a large-scale and costly phase III study to assess its efficacy. A futility design under the null hypothesis assumes that sirolimus will slow the progression of the disease, whereas the alternative hypothesis assumes no benefit of sirolimus. If the null hypothesis is rejected (i.e., futility of sirolimus to slow progression of MSA), a major phase III study will be discouraged, whereas non-futility will offer strong support for a phase III trial to detect clinical efficacy.
Interventions
- OTHER Placebo
- DRUG Sirolimus 2 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2021-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03589976
The ClinicalTrials.gov registry entry for NCT03589976 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03589976 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03589976 about?
NCT03589976 is a clinical study titled "A Futility Trial of Sirolimus in Multiple System Atrophy". Single-center, randomized, placebo-controlled, phase-II, futility clinical trial to determine if oral sirolimus is of sufficient promise to slow disease progression in MSA, prior to embarking on a large-scale and costly phase III study to assess its efficacy. A futility design under the null hypothe...
What is the current status of trial NCT03589976?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2018-09-01. Estimated completion is 2021-01-01.
What interventions are being tested in trial NCT03589976?
The interventions under investigation include: Placebo (OTHER), Sirolimus 2 MG (DRUG).
Who is sponsoring clinical trial NCT03589976?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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