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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393600
First Posted: July 13, 2011
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurocrine Biosciences
July 11, 2011
July 13, 2011
May 11, 2017
August 10, 2017
August 10, 2017
August 2011
February 2012   (Final data collection date for primary outcome measure)
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score [ Time Frame: Day 15 and 29, averaged ]
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
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 ]
Abnormal Involuntary Movements Scale (AIMS)
Complete list of historical versions of study NCT01393600 on ClinicalTrials.gov Archive Site
Clinical Global Impression - Global Improvement of TD (CGI-TD) [ Time Frame: Day 15 and 29, averaged ]
Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
  • 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 ]
    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 ]

    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)
  • Evaluation of plasma exposure measures of NBI-98854 following repeated daily doses (12.5 and 50 mg) of NBI-98854. [ Time Frame: 35 days ]
    Blood samples will be collected and analyzed to evaluate drug and metabolite plasma concentrations.
Not Provided
Not Provided
 
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Tardive Dyskinesia
  • Drug: NBI-98854
    12.5 mg powder in bottle once daily for 14 days
  • Drug: NBI-98854
    50 mg powder in bottle once daily for 14 days
  • Drug: Placebo
    Solution containing no active substance
  • 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.

    Interventions:
    • Drug: NBI-98854
    • Drug: Placebo
  • 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.

    Interventions:
    • Drug: NBI-98854
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
February 2012
February 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01393600
NBI-98854-1101
No
Not Provided
Not Provided
Neurocrine Biosciences
Neurocrine Biosciences
Not Provided
Study Director: Christopher O'Brien, MD Neurocrine Biosciences
Neurocrine Biosciences
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP