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NCT02736955 · ClinicalTrials.gov registry record · Phase 3
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
A Phase 3 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
NCT02736955: Completed Phase 3 study, sponsored by Neurocrine Biosciences.
NCT02736955 is a Phase 3 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 161 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02736955, a Phase 3 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
Study Summary
This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
Primary Outcome
Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
Interventions
- DRUG Valbenazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2016-06-13 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 3 |
What the finished NCT02736955 record still lists
NCT02736955 is an interventional study that assigns participants to a tested intervention. The registered 161 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 (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Valbenazine is the first listed.
NCT02736955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02736955 about?
NCT02736955 is a clinical study titled "Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia". This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 w...
What is the current status of trial NCT02736955?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2016-06-13. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT02736955?
The interventions under investigation include: Valbenazine (DRUG).
Who is sponsoring clinical trial NCT02736955?
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 NCT02736955's enrollment target sits among peer trials
161 1478th of 2000 higher than 522 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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