Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Last updated: March 7, 2025
Sponsor: Biohaven Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Obsessive-compulsive Disorder

Panic Disorders

Anxiety Disorders

Treatment

Placebo

Troriluzole

Clinical Study ID

NCT04641143
BHV4157-302
  • Ages 18-65
  • All Genders

Study Summary

The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic andStatistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI atScreening; The duration of the subject's illness must be ≥ 1 year

  2. An inadequate response to current Standard of Care medication defined as selectiveserotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at anadequate and stable dose for at least 8 weeks prior to screening and at least 12weeks at baseline (adequate dose defined by USPI labeling); an inadequate responseas defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinicalbenefit as perceived by the subject

  3. Determined by the investigator to be medically stable at baseline/randomization asassessed by medical history, physical examination, laboratory test results, andelectrocardiogram testing. Subjects must be physically able and expected to completethe trial as designed

Exclusion

Exclusion Criteria:

  1. Subjects with a history of more than two (2) previous failed or inadequate treatmentclasses given for an adequate duration at an adequate dose as defined by theMGH-TRQ-OCD.

  2. Current or prior history of: bipolar I or II disorder, schizophrenia or otherpsychotic disorders, schizoaffective disorder, autism or autistic spectrumdisorders, borderline personality disorder, antisocial personality disorder,Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery,Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medicalcondition that may confound safety and/or efficacy results

  3. Previous treatment in a study with troriluzole

Study Design

Total Participants: 700
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 22, 2020
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Metropolitan Neuro Behavioral Institute

    Chandler, Arizona 85284
    United States

    Completed

  • IMA Clinical Research

    Phoenix, Arizona 85012
    United States

    Active - Recruiting

  • NoeisisPharma, LLC

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Metropolitan Neuro Behavioral Institute

    Tempe, Arizona 85284
    United States

    Site Not Available

  • Atria Clinical Research

    Little Rock, Arkansas 72209
    United States

    Site Not Available

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Site Not Available

  • CITrials (Clinical Innovations)

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    United States

    Completed

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    Colton, California 92324
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    Site Not Available

  • Global Clinical Trials

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    United States

    Site Not Available

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    Encino, California 91316
    United States

    Active - Recruiting

  • Behavioral Research Specialists, LLC

    Glendale, California 91206
    United States

    Active - Recruiting

  • Synergy Research San Diego

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Pharmacology Research Institute

    Los Alamitos, California 90720
    United States

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  • Clarity Clinical Research

    Los Angeles, California 90064
    United States

    Active - Recruiting

  • Pharmacology Research Institute (WR-PRI, LLC)

    Newport Beach, California 92660
    United States

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    Oakland, California 94607
    United States

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    Oceanside, California 92056
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    Orange, California 92688
    United States

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    Redlands, California 92374
    United States

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    San Diego, California 92119
    United States

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    San Jose, California 95124
    United States

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    Sherman Oaks, California 91403
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    Stanford, California 94305
    United States

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    Torrance, California 90502
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    New Haven, Connecticut 06519
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    New London, Connecticut 06320
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    Norwich, Connecticut 06360
    United States

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    Boca Raton, Florida 33431
    United States

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    Coral Gables, Florida 33134
    United States

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    United States

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    Hialeah, Florida 33016
    United States

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    United States

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    Decatur, Georgia 30030
    United States

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    Savannah, Georgia 31405
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    United States

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    Elgin, Illinois 60123
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    Libertyville, Illinois 60048
    United States

    Site Not Available

  • AMR-Baber Research, Inc

    Naperville, Illinois 60563
    United States

    Active - Recruiting

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    Wauconda, Illinois 60084
    United States

    Site Not Available

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    Overland Park, Kansas 66210
    United States

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    Bangor, Maine 04401
    United States

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    Gaithersburg, Maryland 20877
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    Pikesville, Maryland 21208
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    Methuen, Massachusetts 01844
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  • Sisu at RMG

    Springfield, Massachusetts 01103
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  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan 48105
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  • Precise Research Centers

    Flowood, Mississippi 39232
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  • Healthcare Research Network

    Hazelwood, Missouri 63042
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    O'Fallon, Missouri 63368
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    Mount Kisco, New York 10549
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    New York, New York 10036
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  • Richmond Behavioral Associates

    Staten Island, New York 10312
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  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina 28303
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    Beavercreek, Ohio 45431
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    Canton, Ohio 44718
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    Dayton, Ohio 45417
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    Site Not Available

  • Central States Research, LLC

    Tulsa, Oklahoma 74136
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  • Suburban Research Associates

    Media, Pennsylvania 19063
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  • Global Medical Institutes, LLC, Scranton Medical Institute

    Moosic, Pennsylvania 18507
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  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
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  • Comprehensive Psychiatric Care Providers

    Providence, Rhode Island 02906
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    Austin, Texas 78759
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    Houston, Texas 77081
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  • SMS Clinical Research

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Mt.Olympus Medical Research LLC

    Missouri City, Texas 77459
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    Completed

  • Grayline Research Center

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Active - Recruiting

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