Aim to Reduce Movements in Tardive Dyskinesia

Last updated: November 5, 2021
Sponsor: Auspex Pharmaceuticals, Inc.
Overall Status: Completed

Phase

2/3

Condition

Dyskinesias

Tardive Dyskinesia

Treatment

N/A

Clinical Study ID

NCT02195700
SD-809-C-18
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine whether an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of using a dopamine receptor antagonist for at least 3 months
  • Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 monthsprior to screening
  • Subjects with underlying psychiatric diagnosis are stable and have no change inpsychoactive medications
  • Have a mental health provider and does not anticipate any changes to treatment regimenin the next 3 months
  • History of being compliant with prescribed medications
  • Able to swallow study drug whole
  • Be in good general health and is expected to attend all study visits and completestudy assessments
  • Female subjects must not be pregnant and agree to an acceptable method ofcontraception

Exclusion

Exclusion Criteria:

  • Currently receiving medication for the treatment of tardive dyskinesia
  • Have a neurological condition other than tardive dyskinesia that may interfere withassessing the severity of dyskinesias
  • Have a serious untreated or undertreated psychiatric illness
  • Have recent history or presence of violent behavior
  • Have unstable or serious medical illness
  • Have evidence of hepatic impairment
  • Have evidence of renal impairment
  • Have known allergy to any component of SD-809 or tetrabenazine
  • Has participated in an investigational drug or device trial and received study drugwithin 30 days
  • Have acknowledged use of illicit drugs
  • Have a history of alcohol or substance abuse in the previous 12 months

Study Design

Total Participants: 117
Study Start date:
June 01, 2014
Estimated Completion Date:
May 31, 2015

Connect with a study center

  • Prague,
    Czechia

    Site Not Available

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    Bydogoszcz,
    Poland

    Site Not Available

  • Gdansk,
    Poland

    Site Not Available

  • Katowice,
    Poland

    Site Not Available

  • Krakow,
    Poland

    Site Not Available

  • Lodz,
    Poland

    Site Not Available

  • Lublin,
    Poland

    Site Not Available

  • Torun,
    Poland

    Site Not Available

  • Hronovce,
    Slovakia

    Site Not Available

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    Rimavska,
    Slovakia

    Site Not Available

  • Roznava,
    Slovakia

    Site Not Available

  • Tuscaloosa, Alabama
    United States

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  • Anaheim, California
    United States

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  • Glendale, California
    United States

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  • Oceanside, California
    United States

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  • Orange, 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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  • Denver, Colorado
    United States

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  • New Haven, Connecticut
    United States

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  • Stamford, Connecticut
    United States

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  • Washington, District of Columbia
    United States

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    Washington, D.C., District of Columbia
    United States

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  • Boca Raton, Florida
    United States

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  • Gainesville, Florida
    United States

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  • Lake City, Florida
    United States

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  • Miami, Florida
    United States

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  • Orlando, Florida
    United States

    Site Not Available

  • Port Charlotte, Florida
    United States

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  • Chicago, Illinois
    United States

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  • Baltimore, Maryland
    United States

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  • Minneapolis, Minnesota
    United States

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  • Kansas City, Missouri
    United States

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  • Saint Louis, Missouri
    United States

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    St. Louis, Missouri
    United States

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  • Albuquerque, New Mexico
    United States

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  • Asheville, North Carolina
    United States

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  • Durham, North Carolina
    United States

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  • Raleigh, North Carolina
    United States

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  • Cleveland, Ohio
    United States

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  • Philadelphia, Pennsylvania
    United States

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  • Charleston, South Carolina
    United States

    Site Not Available

  • Memphis, Tennessee
    United States

    Site Not Available

  • Fort Worth, Texas
    United States

    Site Not Available

  • Salt Lake City, Utah
    United States

    Site Not Available

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