Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

Last updated: January 11, 2025
Sponsor: Biohaven Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Panic Disorders

Obsessive-compulsive Disorder

Mood Disorders

Treatment

Troriluzole

Placebo

Clinical Study ID

NCT04693351
BHV4157-303
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Key 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 subjects illness must be ≥ 1year

  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 responsetoo current standard of car base on the YBOCS score.

  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 trail as designed.

Exclusion

Key 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 autism spectrum disorders,borderline personality disorder, antisocial personality disorder, Tourette'sdisorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep BrainStimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical conditionthat 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: Troriluzole
Phase: 3
Study Start date:
January 29, 2021
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Chatham-Kent Clinical Trials Research Centre

    Chatham, Ontario N7L 1C1
    Canada

    Site Not Available

  • McMaster University, Hamilton Health Sciences

    Hamilton, Ontario L8S 1B7
    Canada

    Site Not Available

  • Queen's University

    Kingston, Ontario K7L 5G2
    Canada

    Site Not Available

  • START Clinic for Mood and Anxiety Disorders

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • University of Toronto / Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario M6J 1H4
    Canada

    Site Not Available

  • Beijing HuiLongGuan Hospital

    Beijing, Changping District 100085
    China

    Site Not Available

  • Peking University Sixth Hospital

    Beijing, Haidian District 100083
    China

    Site Not Available

  • Hangzhou Seventh People's Hospital

    Hangzhou, Hangzhou City 310063
    China

    Site Not Available

  • Tianjin Anding Hospital

    Tianjin, Hexi District 300222
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Xiangya, Hunan 410008
    China

    Site Not Available

  • Nanjing Brain Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Shanghai Mental Health Center

    Shanghai, Minhang District 201108
    China

    Site Not Available

  • Wuhan Mental Health Center

    Wuhan, Qiaokou District 430022
    China

    Site Not Available

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Tianhe District 510660
    China

    Site Not Available

  • Mental Health Center, West China Hospital, Sichuan University

    Chengdu, Wuhou District 610041
    China

    Site Not Available

  • First Hospital of Hebei Medical University

    Shijiazhuang, Yuhua District 050001
    China

    Site Not Available

  • Institute of Neuroscience, University of Firenze

    Florence, 50121
    Italy

    Site Not Available

  • ASST FBF SACCO - Ospedale Universitario Luigi Sacco

    Milan, 20157
    Italy

    Site Not Available

  • University School of Medicine of Napoli Federico II

    Naples, 80131
    Italy

    Site Not Available

  • University of Pisa

    Pisa, 56126
    Italy

    Site Not Available

  • University of Turin - university hospital san luigi gonzaga

    Turin, 10043
    Italy

    Site Not Available

  • Amsterdam UMC, locatie AMC

    Amsterdam, 1100
    Netherlands

    Site Not Available

  • Leiden University Medical Center (LUMC)

    Leiden, 2333
    Netherlands

    Site Not Available

  • Barbara Diaz Hernandez MD Research, Inc.

    San Juan, 00926
    Puerto Rico

    Site Not Available

  • Hospital Universitario de Bellvitge

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Centro de Salud Mental La Corredoria

    Oviedo, 33011
    Spain

    Site Not Available

  • Centro de Salud San Juan

    Salamanca, 37005
    Spain

    Site Not Available

  • Hospital Álvaro Cunqueiro

    Vigo, 36312
    Spain

    Site Not Available

  • MAC Clinical Research

    Stockton-on-Tees, County Durham TS17 6EW
    United Kingdom

    Site Not Available

  • Stemax Consult - Healthcare Services Ltd

    Stony Stratford, Northamptonshire MK19 6FG
    United Kingdom

    Site Not Available

  • MAC Clinical Research - South Staffordshire

    Cannock, South Staffordshire WS11 0BN
    United Kingdom

    Site Not Available

  • MAC Clinical Research-Lancashire

    Blackpool, FY2 0JH
    United Kingdom

    Site Not Available

  • Surrey and Borders Partnership NHS Foundation Trust

    Chertsey, KT16 0AE
    United Kingdom

    Site Not Available

  • MAC Clinical Research

    Leeds, LS10 1DU
    United Kingdom

    Site Not Available

  • MAC Clinical Research -- Merseyside

    Liverpool, L34 1BH
    United Kingdom

    Site Not Available

  • South West London and St George's Mental Health NHS Trust Springfield University Hospital

    London, SW17 7DJ
    United Kingdom

    Site Not Available

  • Greater Manchester Mental Health NHS Foundation Trust

    Manchester, M25 3BL
    United Kingdom

    Site Not Available

  • Bioluminux Ltd

    Milton Keynes, MK15 0DU
    United Kingdom

    Site Not Available

  • Kingshill Research Centre

    Swindon, SN3 6BW
    United Kingdom

    Site Not Available

  • MAC Clinical Research-- South Yorkshire

    Tankersley, S75 3DL
    United Kingdom

    Site Not Available

  • Alea Research

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Southern California Research, LLC

    Beverly Hills, California 90210
    United States

    Site Not Available

  • ProScience Research Group

    Culver City, California 90230
    United States

    Site Not Available

  • Sun Valley Research Center, Inc.

    Imperial, California 92251
    United States

    Site Not Available

  • Kaizen Brain Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Om Research LLC

    Lancaster, California 93534
    United States

    Site Not Available

  • ASCLEPES ResearchCEnters, P.C.

    Long Beach, California 90807
    United States

    Site Not Available

  • CalNeuro Research Group

    Los Angeles, California 90024
    United States

    Site Not Available

  • North County Clinical Research

    Oceanside, California 92054
    United States

    Site Not Available

  • CI Trials

    Riverside, California 92506
    United States

    Site Not Available

  • PCSD~Feighner Research

    San Diego, California 92108
    United States

    Site Not Available

  • Lumos Clinical Research Center, LLC

    San Jose, California 95124
    United States

    Site Not Available

  • Velocity Clinical Research

    Santa Ana, California 92704
    United States

    Site Not Available

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Pacific Clinical Research Medical Group

    Upland, California 91786
    United States

    Site Not Available

  • Mountain View Clinical Research

    Denver, Colorado 80209
    United States

    Site Not Available

  • Institute of Living / Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Comprehensive Psychiatric Care

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Topaz Clinical Research

    Apopka, Florida 32703
    United States

    Site Not Available

  • CNS Research of Coral Springs

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • University of Florida Department of Psychiatry

    Gainesville, Florida 32606
    United States

    Site Not Available

  • Qway Research, LLC

    Hialeah, Florida 33010
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Pharmaceutical Research Center, Inc.

    Lutz, Florida 33548
    United States

    Site Not Available

  • Clintex Research

    Miami, Florida 33135
    United States

    Site Not Available

  • Ezy Medical Research, Co.

    Miami, Florida 33175
    United States

    Site Not Available

  • Med-Care Research

    Miami, Florida 33165
    United States

    Site Not Available

  • Miami Dade Medical Research Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • Advanced Research for Health Improvement

    Naples, Florida 34102
    United States

    Site Not Available

  • Bravo Health Care Center

    North Bay Village, Florida 33141
    United States

    Site Not Available

  • Harmony Clinical Research

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • dTMS Center LLC

    Palm Beach, Florida 33480
    United States

    Site Not Available

  • DMI Research

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Olympian Clinical Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • CenExel iResearch

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Renew Health Clinical Research, LLC

    Snellville, Georgia 30078
    United States

    Site Not Available

  • University of Chicago Department of Psychiatry & Behavioral Neuroscience

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Healthcare Research Network II, LLC

    Flossmoor, Illinois 60422
    United States

    Site Not Available

  • AMR-Baber Research, Inc.

    Naperville, Illinois 60563
    United States

    Site Not Available

  • Collective Medical Research

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Collective Medical Research

    Prairie Village, Kansas 66208
    United States

    Site Not Available

  • Riverstar Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Continental Clinical Solutions, LLC

    Towson, Maryland 21204
    United States

    Site Not Available

  • Boston Clinical Trials

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Adams Clinical

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Psychiatric Care and Research Center

    O'Fallon, Missouri 63368
    United States

    Site Not Available

  • Boeson Research

    Missoula, Montana 59804
    United States

    Site Not Available

  • Center for Emotional Fitness

    Cherry Hill, New Jersey 08028
    United States

    Site Not Available

  • SPRI Clinical Trials, LLC

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Manhattan Behavioral Medicine, PLLC

    New York, New York 10036
    United States

    Site Not Available

  • Finger Lakes Clinical Research

    Rochester, New York 14618
    United States

    Site Not Available

  • ARSMNC

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Richard H. Weisler, MD PA & Associates

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • American Clinical Research Institute (ACRI)

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Neurology Diagnostics, Inc.

    Dayton, Ohio 45459
    United States

    Site Not Available

  • American Research Institute (ACRI)

    Kettering, Ohio 45439
    United States

    Site Not Available

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • IPS Research

    Oklahoma City, Oklahoma 73106
    United States

    Site Not Available

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Suburban Research Associates

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Coastal Carolina Research Center

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Donald J. Garcia Jr., MD PA

    Austin, Texas 78737
    United States

    Site Not Available

  • Inquest Clinical Research

    Baytown, Texas 77521
    United States

    Site Not Available

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas 75231
    United States

    Site Not Available

  • InSite Clinical Research

    DeSoto, Texas 75115
    United States

    Site Not Available

  • NovoTrial Research Group

    Frisco, Texas 75033
    United States

    Site Not Available

  • Clinical Trial Network

    Houston, Texas 77074
    United States

    Site Not Available

  • AIM Trials

    Plano, Texas 75093
    United States

    Site Not Available

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Woodstock Research Center

    Woodstock, Vermont 05091
    United States

    Site Not Available

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