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

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Brief Title

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score

Secondary Outcome

 Clinical Global Impression - Global Improvement of TD (CGI-TD)

Condition

Tardive Dyskinesia

Intervention

NBI-98854

Study Arms / Comparison Groups

 NBI-98854 12.5 mg
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

37

Start Date

August 2011

Completion Date

February 2012

Primary Completion Date

February 2012

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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Christopher O'Brien, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01393600

Organization ID

NBI-98854-1101


Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences


Study Sponsor

Christopher O'Brien, MD, Study Director, Neurocrine Biosciences


Verification Date

July 2017