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NCT01897896 · ClinicalTrials.gov registry record · Phase 3
Alternatives for Reducing Chorea in Huntington Disease
A Phase 3 study, sponsored by Auspex Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT01897896: Completed Phase 3 study, sponsored by Auspex Pharmaceuticals.
NCT01897896 is a Phase 3 study that has completed, run by Auspex Pharmaceuticals. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01897896, a Phase 3 study, has completed, sponsored by Auspex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in "Switch" participants as well as "Rollover" participants completing a randomized, double blind, placebo-controlled study of SD-809 ER.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=inability to carry out usual activities. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth
Interventions
- DRUG SD-809
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2013-11-12 |
| Est. Completion | 2017-08-21 |
| Phase | Phase 3 |
What the finished NCT01897896 record still lists
NCT01897896 is an interventional study that assigns participants to a tested intervention. The registered 119 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which SD-809 is the first listed.
NCT01897896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01897896 about?
NCT01897896 is a clinical study titled "Alternatives for Reducing Chorea in Huntington Disease". The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of SD-809 extended release (ER) in participants switching from tetrabenazine to SD-809 ER. In addition, the safety and tolerability of long-term treatment with SD-809 ER will be assessed in "Switch" participants ...
What is the current status of trial NCT01897896?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2013-11-12. Estimated completion is 2017-08-21.
What interventions are being tested in trial NCT01897896?
The interventions under investigation include: SD-809 (DRUG).
Who is sponsoring clinical trial NCT01897896?
This trial is sponsored by Auspex Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01897896's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 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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