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

Purpose

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.

Condition	Intervention	Phase
Tardive Dyskinesia	Drug: NBI-98854 Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Neurocrine Biosciences:

Primary Outcome Measures:

Efficacy of 12.5 or 50 mg doses of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Abnormal Involuntary Movements Scale (AIMS)

Secondary Outcome Measures:

Efficacy of 12.5 or 50 mg doses of NBI-98854 administered once daily for the treatment of tardive dyskinesia (TD) symptoms [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Clinical Global Impression of Tardive Dyskinesia (CGI-TD) and a Patient Global Impression of Change (PGIC) questionnaire.
Number of Participants with Adverse Events following dosing with NBI-98854 [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
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
Evaluation of plasma exposure measures of NBI-98854 following repeated daily doses (12.5 and 50 mg) of NBI-98854. [ Time Frame: 35 days ] [ Designated as safety issue: No ]
Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.

Enrollment:	37
Study Start Date:	August 2011
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: NBI-98854 12.5 mg powder in bottle once daily for 14 days Drug: Placebo Solution containing no active substance
Experimental: 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.	Drug: NBI-98854 50 mg powder in bottle once daily for 14 days Drug: Placebo Solution containing no active substance

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393600

Locations

United States, Arkansas
Woodland International Research Group, Inc
Little Rock, Arkansas, United States, 72211
United States, California
Synergy Clinical Research
National City, California, United States, 91950
UCSD Outpatient Psychiatry
San Diego, California, United States, 92103
PCSD - Feighner Research
San Diego, California, United States, 92108
United States, Florida
San Marcus Research Clinic, Inc.
Miami, Florida, United States, 33015
Medical Research Marseilles
Miami, Florida, United States, 33155
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Missouri
St. Louis Clinical Trials
St. Louis, Missouri, United States, 63118
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
United States, West Virginia
CAMC Clinical Trials Center
Charleston, West Virginia, United States, 25304

Sponsors and Collaborators

Neurocrine Biosciences

Investigators

Study Director:

Christopher O'Brien, MD

Neurocrine Biosciences

More Information

No publications provided

Responsible Party:	Neurocrine Biosciences
ClinicalTrials.gov Identifier:	NCT01393600 History of Changes
Other Study ID Numbers:	NBI-98854-1101
Study First Received:	July 11, 2011
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dyskinesias
Psychotic Disorders
Schizophrenia
Movement Disorders
Central Nervous System Diseases

Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013