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NCT01733121 · ClinicalTrials.gov registry record · Phase 2
NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
A Phase 2 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT01733121: Completed Phase 2 study, sponsored by Neurocrine Biosciences.
NCT01733121 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01733121, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Primary Outcome
The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Interventions
- DRUG Placebo
- DRUG NBI-98854
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01733121 record still lists
NCT01733121 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01733121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01733121 about?
NCT01733121 is a clinical study titled "NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia". The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
What is the current status of trial NCT01733121?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2012-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01733121?
The interventions under investigation include: Placebo (DRUG), NBI-98854 (DRUG).
Who is sponsoring clinical trial NCT01733121?
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 NCT01733121's enrollment target sits among peer trials
102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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