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NCT02731690 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety of Aceneuramic Acid Extended Release (Ace-ER; UX001) Tablets in Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy (GNEM) (Also Known as Hereditary Inclusion Body Myopathy [HIBM]) Patients With Severe Ambulatory Impairment
A Phase 2 study, sponsored by Ultragenyx Pharmaceutical.
- Terminated
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02731690 is a Phase 2 study that was terminated before completion, run by Ultragenyx Pharmaceutical. The registered enrollment target is 42 participants.
The verdict
NCT02731690, a Phase 2 study, was terminated before completion, sponsored by Ultragenyx Pharmaceutical.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The primary objective of this Phase 2 study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM participants with severe ambulatory impairment.
Interventions
- DRUG Aceneuramic Acid Extended-Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-04-29 |
| Est. Completion | 2018-01-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02731690
The ClinicalTrials.gov registry entry for NCT02731690 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ultragenyx Pharmaceutical, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aceneuramic Acid Extended-Release is the first listed.
NCT02731690 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02731690 about?
NCT02731690 is a clinical study titled "A Study to Evaluate the Safety of Aceneuramic Acid Extended Release (Ace-ER; UX001) Tablets in Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy (GNEM) (Also Known as Hereditary Inclusion Body Myopathy [HIBM]) Patients With Severe Ambulatory Impairment". The primary objective of this Phase 2 study is to evaluate the safety of open-label 6 g/day Ace-ER in GNEM participants with severe ambulatory impairment.
What is the current status of trial NCT02731690?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2016-04-29. Estimated completion is 2018-01-10.
What interventions are being tested in trial NCT02731690?
The interventions under investigation include: Aceneuramic Acid Extended-Release (DRUG).
Who is sponsoring clinical trial NCT02731690?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
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