A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Last updated: June 9, 2017
Sponsor: Neurocrine Biosciences
Overall Status: Completed

Phase

3

Condition

Tardive Dyskinesia

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT02274558
NBI-98854-1304
  • Ages 18-85
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects of childbearing potential must agree to use hormonal or two forms ofnonhormonal contraception (dual contraception) consistently during the screening,treatment and follow-up periods of the study.

  2. Female subjects must not be pregnant.

  3. Have one of the following clinical diagnoses for at least 3 months prior to screening:Schizophrenia or Schizoaffective Disorder, or Mood Disorder.

  4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior toscreening.

  5. Have moderate or severe TD.

  6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, ormood disorder, be on stable doses.

  7. Be in good general health.

  8. Have adequate hearing, vision, and language skills to perform the procedures specifiedin the protocol.

  9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines,phencyclidine, cocaine, opiates, or cannabinoids

Exclusion

Exclusion Criteria:

  1. Have an active, clinically significant unstable medical condition within 1 month priorto screening.

  2. Have a known history of substance dependence, or substance (drug) or alcohol abuse

  3. Have a significant risk of suicidal or violent behavior.

  4. Have a known history of neuroleptic malignant syndrome.

  5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.

  6. Have a cancer diagnosis within 3 years of screening (some exceptions allowed)

  7. Have received an investigational drug within 30 days prior to screening or plan to usean investigational drug (other than NBI-98854) during the study.

  8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.

  9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

  10. Have had previous exposure with NBI-98854 or had previously participated in anNBI-98854 clinical study.

  11. Are currently pregnant or breastfeeding.

Study Design

Total Participants: 234
Study Start date:
October 01, 2014
Estimated Completion Date:
July 31, 2016

Study Description

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.

Connect with a study center

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • London, Ontario
    Canada

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  • Toronto, Ontario
    Canada

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  • Montreal, Quebec
    Canada

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  • Caguas,
    Puerto Rico

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  • San Juan,
    Puerto Rico

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  • Little Rock, Arkansas
    United States

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  • Anaheim, California
    United States

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  • Glendale, California
    United States

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  • Irvine, California
    United States

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  • Long Beach, California
    United States

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  • Los Angeles, California
    United States

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  • National City, California
    United States

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  • Norwalk, California
    United States

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  • Oakland, California
    United States

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  • Oceanside, California
    United States

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    San Bernandino, California
    United States

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  • San Bernardino, California
    United States

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  • San Diego, California
    United States

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  • Torrance, California
    United States

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  • Bradenton, Florida
    United States

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  • Hialeah, Florida
    United States

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  • Kissimmee, Florida
    United States

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  • Leesburg, Florida
    United States

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  • Maitland, Florida
    United States

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  • Miami, Florida
    United States

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  • North Miami, Florida
    United States

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  • Chicago, Illinois
    United States

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  • Oak Brook, Illinois
    United States

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  • Shreveport, Louisiana
    United States

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  • Baltimore, Maryland
    United States

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  • Glen Burnie, Maryland
    United States

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  • Worcester, Massachusetts
    United States

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  • Flowood, Mississippi
    United States

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  • Saint Louis, Missouri
    United States

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    St. Louis, Missouri
    United States

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  • Lincoln, Nebraska
    United States

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  • Amherst, New York
    United States

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  • Cedarhurst, New York
    United States

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  • Rochester, New York
    United States

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  • Durham, North Carolina
    United States

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  • Pinehurst, North Carolina
    United States

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  • Dayton, Ohio
    United States

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  • Shaker Heights, Ohio
    United States

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  • Oklahoma City, Oklahoma
    United States

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  • Conshohocken, Pennsylvania
    United States

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  • Norristown, Pennsylvania
    United States

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    Pheonixville, Pennsylvania
    United States

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  • Phoenixville, Pennsylvania
    United States

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  • Scranton, Pennsylvania
    United States

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  • Charleston, South Carolina
    United States

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  • Memphis, Tennessee
    United States

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  • DeSoto, Texas
    United States

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  • Fort Worth, Texas
    United States

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  • Irving, Texas
    United States

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  • Petersburg, Virginia
    United States

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  • Spokane, Washington
    United States

    Site Not Available

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