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NCT02198794 · ClinicalTrials.gov registry record · Phase 3
Reducing Involuntary Movements in Participants With Tardive Dyskinesia
A Phase 3 study, sponsored by Auspex Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 343
- Enrollment target
NCT02198794: Completed Phase 3 study, sponsored by Auspex Pharmaceuticals.
NCT02198794 is a Phase 3 study that has completed, run by Auspex Pharmaceuticals. The registered enrollment target is 343 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02198794, a Phase 3 study, has completed, sponsored by Auspex Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 343 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.
Primary Outcome
AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disabili
Interventions
- DRUG Placebo
- DRUG SD-809
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2014-10-20 |
| Est. Completion | 2020-12-14 |
| Phase | Phase 3 |
What the finished NCT02198794 record still lists
NCT02198794 is an interventional study that assigns participants to a tested intervention. The registered 343 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 (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02198794 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02198794 about?
NCT02198794 is a clinical study titled "Reducing Involuntary Movements in Participants With Tardive Dyskinesia". The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of...
What is the current status of trial NCT02198794?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2014-10-20. Estimated completion is 2020-12-14.
What interventions are being tested in trial NCT02198794?
The interventions under investigation include: Placebo (DRUG), SD-809 (DRUG).
Who is sponsoring clinical trial NCT02198794?
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 NCT02198794's enrollment target sits among peer trials
343 1051st of 2000 higher than 948 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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