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

NCT ID: NCT01393600

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-02-29

Brief 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

Tardive Dyskinesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NBI-98854 12.5 mg

During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28.

Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.

Group Type: EXPERIMENTAL

NBI-98854

Intervention Type: DRUG

12.5 mg powder in bottle once daily for 14 days

Placebo

Intervention Type: DRUG

Solution containing no active substance

NBI-98854 50 mg

During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences:

Sequence 3: Placebo once daily dose for Days 1-14 and 50 mg NBI-98854 once daily dose for Days 15-28.

Sequence 4: 50 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28.

Group Type: EXPERIMENTAL

NBI-98854

Intervention Type: DRUG

50 mg powder in bottle once daily for 14 days

Placebo

Intervention Type: DRUG

Solution containing no active substance

Interventions

NBI-98854

12.5 mg powder in bottle once daily for 14 days

Intervention Type: DRUG

NBI-98854

50 mg powder in bottle once daily for 14 days

Intervention Type: DRUG

Placebo

Solution containing no active substance

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurocrine Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher O'Brien, MD

Role: STUDY_DIRECTOR

Neurocrine Biosciences

Locations

Woodland International Research Group, Inc

Little Rock, Arkansas, United States

Synergy Clinical Research

National City, California, United States

UCSD Outpatient Psychiatry

San Diego, California, United States

PCSD - Feighner Research

San Diego, California, United States

San Marcus Research Clinic, Inc.

Miami, Florida, United States

Medical Research Marseilles

Miami, Florida, United States

Scientific Clinical Research, Inc.

North Miami, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

St. Louis Clinical Trials

St Louis, Missouri, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

CAMC Clinical Trials Center

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

NBI-98854-1101

Identifier Type: -

Identifier Source: org_study_id