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NCT02736188 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)
A Phase 3 study, sponsored by Ultragenyx Pharmaceutical.
- Terminated
- Registry status
- Phase 3
- Development phase
- 143
- Enrollment target
NCT02736188: Clinical Trial Phase 3 study, sponsored by Ultragenyx Pharmaceutical.
NCT02736188 is a Phase 3 study that was terminated before completion, run by Ultragenyx Pharmaceutical. The registered enrollment target is 143 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02736188, a Phase 3 study, was terminated before completion, sponsored by Ultragenyx Pharmaceutical.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 143 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.
Primary Outcome
An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the Investigator or Ultragenyx, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability (substantial disruptio
Interventions
- DRUG Aceneuramic Acid Extended-Release Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2016-05-02 |
| Est. Completion | 2018-01-10 |
| Phase | Phase 3 |
Why NCT02736188 stopped before completion
NCT02736188 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Aceneuramic Acid Extended-Release Tablets is the first listed.
NCT02736188 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02736188 about?
NCT02736188 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)". The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.
What is the current status of trial NCT02736188?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 143 participants. The study started on 2016-05-02. Estimated completion is 2018-01-10.
What interventions are being tested in trial NCT02736188?
The interventions under investigation include: Aceneuramic Acid Extended-Release Tablets (DRUG).
Who is sponsoring clinical trial NCT02736188?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02736188's enrollment target sits among peer trials
143 1559th of 2000 higher than 442 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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