NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

Tardive Dyskinesia Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Period Cross-Over Study to Evaluate the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393600
• Other study ID #: NBI-98854-1101
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2011
• Last updated: May 7, 2013
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2013
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), 333.82 (see Appendix 17.1) for at least 3 months prior to screening.

• Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.

• Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.

• Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.

• Female subjects must not be pregnant.

• Be in good general health and expected to complete the clinical study as designed.

• Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).

• Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

• Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.

• Have a negative alcohol breath test at screening and study start.

Exclusion Criteria:

• Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.

• Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary).

• Have a known history of neuroleptic malignant syndrome.

• Have a significant risk of suicidal or violent behavior.

• Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine

• Receiving medication for the treatment of tardive dyskinesia.

• Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.

• Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.

• Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

• Have had previous exposure with NBI-98854.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Psychotic Disorders
• Tardive Dyskinesia

Intervention

Drug:
• NBI-98854
12.5 mg powder in bottle once daily for 14 days
• NBI-98854
50 mg powder in bottle once daily for 14 days
• Placebo
Solution containing no active substance

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	Woodland International Research Group, Inc	Little Rock	Arkansas
United States	Medical Research Marseilles	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	Synergy Clinical Research	National City	California
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	PCSD - Feighner Research	San Diego	California
United States	UCSD Outpatient Psychiatry	San Diego	California
United States	St. Louis Clinical Trials	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of 12.5 or 50 mg doses of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms	Abnormal Involuntary Movements Scale (AIMS)	28 days	No
Secondary	Efficacy of 12.5 or 50 mg doses of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms	Clinical Global Impression of Tardive Dyskinesia (CGI-TD) and a Patient Global Impression of Change (PGIC) questionnaire.	28 days	No
Secondary	Number of Participants with Adverse Events following dosing with NBI-98854	Safety and tolerability monitoring will include the following assessments: Adverse Events; Clinical lab tests (hematology, serum chemistry, and urinalysis); Vital signs; Physical examinations; 12-lead electrocardiograms (ECG); Brief Psychiatric Rating Scale (BPRS); Columbia Suicide Severity Rating Scale (C-SSRS); Calgary Depression Scale for Schizophrenia (CDSS); Barnes Akathisia Rating Scale (BARS); Simpson-Angus Scale (SAS); Serum Prolactin	35 days	Yes
Secondary	Evaluation of plasma exposure measures of NBI-98854 following repeated daily doses (12.5 and 50 mg) of NBI-98854.	Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.	35 days	No