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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 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.

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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.

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

FieldValue
Enrollment Target 37 participants
Start Date 2011-08
Est. Completion 2012-02
Phase Phase 2

Sponsor

Neurocrine Biosciences

65 total trials

What the Registry Record Tells You About NCT01393600

The ClinicalTrials.gov registry entry for NCT01393600 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 5 other Tardive Dyskinesia trials with a reported enrollment target (74% lower). The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 7 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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