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NCT03891862 · ClinicalTrials.gov registry record · Phase 4
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
A Phase 4 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 135
- Enrollment target
NCT03891862: Completed Phase 4 study, sponsored by Neurocrine Biosciences.
NCT03891862 is a Phase 4 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 135 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03891862, a Phase 4 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 135 participants
- Enrollment target
Study Summary
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
Primary Outcome
The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements. The AIMS Dyskinesia Total Score is the sum of items 1-7 and ranges from 0 to 28, with higher scores indicating more severe dyskinesia. Least-squares mean were estimated using a mixed-effects model for repeated measures.
Interventions
- DRUG Placebo oral capsule
- DRUG Valbenazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2019-03-18 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 4 |
What the finished NCT03891862 record still lists
NCT03891862 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03891862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03891862 about?
NCT03891862 is a clinical study titled "Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia". This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
What is the current status of trial NCT03891862?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 135 participants. The study started on 2019-03-18. Estimated completion is 2020-01-30.
What interventions are being tested in trial NCT03891862?
The interventions under investigation include: Placebo oral capsule (DRUG), Valbenazine (DRUG).
Who is sponsoring clinical trial NCT03891862?
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 NCT03891862's enrollment target sits among peer trials
135 601st of 2000 higher than 1,395 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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