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NCT01393600 · ClinicalTrials.gov registry record · Phase 2
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
A Phase 2 study of Tardive Dyskinesia, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 11
- Study locations
NCT01393600: Completed Phase 2 study of Tardive Dyskinesia, sponsored by Neurocrine Biosciences.
NCT01393600 is a Phase 2 study of Tardive Dyskinesia that has completed, run by Neurocrine Biosciences. The registered enrollment target is 37 participants, below the 142-participant average among 5 other Tardive Dyskinesia trials with a reported enrollment target (74% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393600, a Phase 2 study of Tardive Dyskinesia, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.
Primary Outcome
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. 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 incr
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NBI-98854
Study Locations (11)
California
- Synergy Clinical Research - National City
- UCSD Outpatient Psychiatry - San Diego
- PCSD - Feighner Research - San Diego
Florida
- San Marcus Research Clinic, Inc. - Miami
- Medical Research Marseilles - Miami
- Scientific Clinical Research, Inc. - North Miami
Arkansas
- Woodland International Research Group, Inc - Little Rock
Georgia
- Atlanta Center for Medical Research - Atlanta
Missouri
- St. Louis Clinical Trials - St Louis
Texas
- Clinical Trials of Texas, Inc. - San Antonio
West Virginia
- CAMC Clinical Trials Center - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01393600 record still lists
NCT01393600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 142-participant average among 5 other Tardive Dyskinesia trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Tardive Dyskinesia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01393600 lists 11 locations in 7 states (California, Florida, Arkansas).
Frequently Asked Questions
What is clinical trial NCT01393600 about?
NCT01393600 is a clinical study titled "NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder". The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.
What is the current status of trial NCT01393600?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2011-08. Estimated completion is 2012-02.
What conditions does trial NCT01393600 study?
This clinical trial studies the following conditions: Tardive Dyskinesia.
What interventions are being tested in trial NCT01393600?
The interventions under investigation include: Placebo (DRUG), NBI-98854 (DRUG).
Who is sponsoring clinical trial NCT01393600?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01393600 being conducted?
This trial has 11 study locations across Arkansas, California, Florida, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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