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NCT04421677 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis
A Phase 1 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04421677 is a Phase 1 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT04421677, a Phase 1 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a pilot study (phase 1 clinical trial) to evaluate the safety and tolerability of phenylbutyrate in IBM. In this open label study, 10 patients with sporadic inclusion body myositis will be treated with phenylbutyrate (3 gm twice daily) for 3 months. There will be a run-in period, during which certain biomarkers will be measured at baseline and at the end of the run-in period in addition to final measurement at the end of the treatment period.
Interventions
- DRUG Phenylbutyrate Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-08-20 |
| Est. Completion | 2022-01-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04421677
The ClinicalTrials.gov registry entry for NCT04421677 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Phenylbutyrate Oral Tablet is the first listed.
NCT04421677 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04421677 about?
NCT04421677 is a clinical study titled "Safety and Tolerability of Phenylbutyrate in Inclusion Body Myositis". This is a pilot study (phase 1 clinical trial) to evaluate the safety and tolerability of phenylbutyrate in IBM. In this open label study, 10 patients with sporadic inclusion body myositis will be treated with phenylbutyrate (3 gm twice daily) for 3 months. There will be a run-in period, during whic...
What is the current status of trial NCT04421677?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-08-20. Estimated completion is 2022-01-20.
What interventions are being tested in trial NCT04421677?
The interventions under investigation include: Phenylbutyrate Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04421677?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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