Clinical trial NCT01393600: NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tardive Dyskinesia
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
timeFrame: Day 15 and 29, averaged
Secondary outcomes:
measure: Clinical Global Impression - Global Improvement of TD (CGI-TD)
timeFrame: Day 15 and 29, averaged
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Group, Inc
state: Arkansas
city: National City
country: United States
facility: Synergy Clinical Research
state: California
city: San Diego
country: United States
facility: UCSD Outpatient Psychiatry
state: California
city: San Diego
country: United States
facility: PCSD - Feighner Research
state: California
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Medical Research Marseilles
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
Study officials:
affiliation: Neurocrine Biosciences
name: Christopher O'Brien, MD
role: STUDY_DIRECTOR
References: