Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01830972 · ClinicalTrials.gov registry record · Phase 2
An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy
A Phase 2 study, sponsored by Ultragenyx Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT01830972 is a Phase 2 study that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 59 participants.
The verdict
NCT01830972, a Phase 2 study, has completed, sponsored by Ultragenyx Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
The safety objectives of the study are to: evaluate additional long-term safety of SA-ER treatment of participants with GNE myopathy previously treated with SA-ER at dose of 6g/day (Part I); evaluate the safety of 12g /day SA (delivered by 1.5g of SA-ER tablets and 1.5g of SA-IR capsules 4 times per day) in the treatment of participants with GNE myopathy (Part II) over a 6 month treatment period; evaluate the safety of SA treatment at both 6g/day and 12 g/day (Part III \[SA-ER/SA-IR\] and Part IV \[SA-ER\]).
Interventions
- DRUG SA-ER 500 mg
- DRUG SA-IR 500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2013-06-04 |
| Est. Completion | 2017-02-14 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01830972
The ClinicalTrials.gov registry entry for NCT01830972 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 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 SA-ER 500 mg is the first listed.
NCT01830972 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01830972 about?
NCT01830972 is a clinical study titled "An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy". The safety objectives of the study are to: evaluate additional long-term safety of SA-ER treatment of participants with GNE myopathy previously treated with SA-ER at dose of 6g/day (Part I); evaluate the safety of 12g /day SA (delivered by 1.5g of SA-ER tablets and 1.5g of SA-IR capsules 4 times per...
What is the current status of trial NCT01830972?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2013-06-04. Estimated completion is 2017-02-14.
What interventions are being tested in trial NCT01830972?
The interventions under investigation include: SA-ER 500 mg (DRUG), SA-IR 500 mg (DRUG).
Who is sponsoring clinical trial NCT01830972?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.