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NCT01688037 · ClinicalTrials.gov registry record · Phase 2
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
A Phase 2 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT01688037: Completed Phase 2 study, sponsored by Neurocrine Biosciences.
NCT01688037 is a Phase 2 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01688037, a Phase 2 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 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. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI
Interventions
- DRUG Placebo
- DRUG NBI-98854
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01688037 record still lists
NCT01688037 is an interventional study that assigns participants to a tested intervention. The registered 109 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 (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01688037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01688037 about?
NCT01688037 is a clinical study titled "NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)". The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
What is the current status of trial NCT01688037?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2012-09. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01688037?
The interventions under investigation include: Placebo (DRUG), NBI-98854 (DRUG).
Who is sponsoring clinical trial NCT01688037?
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 NCT01688037's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 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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