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NCT01993186 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Triheptanoin (UX007) for the Treatment of Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)
A Phase 2 study, sponsored by Ultragenyx Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01993186 is a Phase 2 study that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 36 participants.
The verdict
NCT01993186, a Phase 2 study, has completed, sponsored by Ultragenyx Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The primary objectives of the study are to evaluate the efficacy of UX007 compared to placebo as measured by the reduction from randomization to Week 8 in frequency of seizures and to evaluate the safety of UX007 via adverse event (AE) rates, laboratory values, and electrocardiogram (ECG).
Interventions
- DRUG Placebo
- DRUG UX007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-02-28 |
| Est. Completion | 2017-09-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01993186
The ClinicalTrials.gov registry entry for NCT01993186 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 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.
NCT01993186 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01993186 about?
NCT01993186 is a clinical study titled "Phase 2 Study of Triheptanoin (UX007) for the Treatment of Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)". The primary objectives of the study are to evaluate the efficacy of UX007 compared to placebo as measured by the reduction from randomization to Week 8 in frequency of seizures and to evaluate the safety of UX007 via adverse event (AE) rates, laboratory values, and electrocardiogram (ECG).
What is the current status of trial NCT01993186?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2014-02-28. Estimated completion is 2017-09-20.
What interventions are being tested in trial NCT01993186?
The interventions under investigation include: Placebo (DRUG), UX007 (DRUG).
Who is sponsoring clinical trial NCT01993186?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
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