Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Last updated: November 28, 2018
Sponsor: Neurocrine Biosciences
Overall Status: Completed

Phase

3

Condition

Tardive Dyskinesia

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT02736955
NBI-98854-1506
  • Ages 18-85
  • All Genders

Study Summary

This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

  • Participants of childbearing potential must agree to use hormonal or two forms ofnonhormonal contraception (dual contraception) consistently throughout the study anduntil 30 days after the last dose of valbenazine.

  • If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mooddisorder, or other conditions, be on stable doses.

  • Be in general good health.

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

Exclusion

Exclusion Criteria:

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

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

  • Have a significant risk of suicidal or violent behavior.

  • Have a known history of neuroleptic malignant syndrome.

  • Have a known history of long QT syndrome or cardiac arrhythmia.

  • Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).

  • Have received an investigational drug within 30 days before screening or plan to usean investigational drug (other than valbenazine) during the study.

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

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

  • Are currently pregnant or breastfeeding.

Study Design

Total Participants: 161
Study Start date:
June 13, 2016
Estimated Completion Date:
June 30, 2017

Study Description

This study was terminated after 60 weeks due to the commercial availability of valbenazine.

Connect with a study center

  • Anaheim, California
    United States

    Site Not Available

  • 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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    San Bernadino, 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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  • Hialeah, Florida
    United States

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  • North Miami, Florida
    United States

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    Orlanda, Florida
    United States

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  • Orlando, Florida
    United States

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  • Chicago, Illinois
    United States

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  • Shreveport, Louisiana
    United States

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  • Worcester, Massachusetts
    United States

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  • Cedarhurst, New York
    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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  • Norristown, Pennsylvania
    United States

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  • Charleston, South Carolina
    United States

    Site Not Available

  • Franklin, Tennessee
    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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    Ft. Worth, Texas
    United States

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  • Irving, Texas
    United States

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  • Salt Lake City, Utah
    United States

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  • Petersburg, Virginia
    United States

    Site Not Available

  • Spokane, Washington
    United States

    Site Not Available

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