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NCT02377921 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid 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.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT02377921 is a Phase 3 study that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 89 participants.
The verdict
NCT02377921, a Phase 3 study, has completed, sponsored by Ultragenyx Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the effect of 6 g/day aceneuramic acid extended-release (Ace-ER) treatment of participants with GNEM on upper extremity muscle strength (upper extremity composite \[UEC\] score) as measured by dynamometry.
Interventions
- DRUG Placebo
- DRUG aceneuramic acid extended-release (Ace-ER)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2015-05-20 |
| Est. Completion | 2017-06-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02377921
The ClinicalTrials.gov registry entry for NCT02377921 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 89 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 2 interventions - of which Placebo is the first listed.
NCT02377921 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02377921 about?
NCT02377921 is a clinical study titled "Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)". The primary objective of this study is to evaluate the effect of 6 g/day aceneuramic acid extended-release (Ace-ER) treatment of participants with GNEM on upper extremity muscle strength (upper extremity composite \[UEC\] score) as measured by dynamometry.
What is the current status of trial NCT02377921?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2015-05-20. Estimated completion is 2017-06-09.
What interventions are being tested in trial NCT02377921?
The interventions under investigation include: Placebo (DRUG), aceneuramic acid extended-release (Ace-ER) (DRUG).
Who is sponsoring clinical trial NCT02377921?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
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