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NCT02405091 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
A Phase 3 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 167
- Enrollment target
NCT02405091: Completed Phase 3 study, sponsored by Neurocrine Biosciences.
NCT02405091 is a Phase 3 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 167 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02405091, a Phase 3 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 167 participants
- Enrollment target
Study Summary
Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.
Primary Outcome
Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
Interventions
- DRUG NBI-98854
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-03 |
| Phase | Phase 3 |
What the finished NCT02405091 record still lists
NCT02405091 is an interventional study that assigns participants to a tested intervention. The registered 167 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 (78% lower).
The record links to 0 conditions, and to 1 intervention - of which NBI-98854 is the first listed.
NCT02405091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02405091 about?
NCT02405091 is a clinical study titled "Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia". Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder w...
What is the current status of trial NCT02405091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2015-03. Estimated completion is 2017-03.
What interventions are being tested in trial NCT02405091?
The interventions under investigation include: NBI-98854 (DRUG).
Who is sponsoring clinical trial NCT02405091?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02405091's enrollment target sits among peer trials
167 1463rd of 2000 higher than 538 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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