Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Last updated: January 16, 2025
Sponsor: Biohaven Pharmaceuticals, Inc.
Overall Status: Active - Enrolling

Phase

3

Condition

Obsessive-compulsive Disorder

Panic Disorders

Kleptomania

Treatment

Troriluzole (BHV-4157)

Clinical Study ID

NCT04708834
BHV4157-209
  • Ages 18-65
  • All Genders

Study Summary

The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303and for whom the investigator believes open-label treatment offers an acceptablerisk-benefit profile.

  • Determined by the investigator to be medically stable at the week 10 visit ofBHV4157-302 or BHV4157-303, as assessed by medical history, physical examination,laboratory test results, and electrocardiogram testing.

  • It is required that all women of child-bearing potential (WOCBP) who are sexuallyactive agree to use two methods of contraception for the duration of the study

Exclusion

Key Exclusion Criteria:

  • Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302or BHV4157-303 study.

  • Acute suicidality or suicide attempt or self injurious behavior in the last 12months.

  • Patients who may have received a non-biological investigational agent in anyclinical trial within 30 days or a biological agent within 90 days prior to entry,other than what was received in BHV4157-302 or BHV4157-303;

Study Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Troriluzole (BHV-4157)
Phase: 3
Study Start date:
March 30, 2021
Estimated Completion Date:
June 30, 2026

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

  • 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

  • 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-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 -- 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

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  • MAC Clinical Research-Greater Manchester

    Manchester, M13 9NQ
    United Kingdom

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  • Bioluminux Ltd

    Milton Keynes, MK15 0DU
    United Kingdom

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    Tankersley, S75 3DL
    United Kingdom

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  • Metropolitan Neuro Behavioral Institute

    Chandler, Arizona 85226
    United States

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    Phoenix, Arizona 85012
    United States

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    Phoenix, Arizona 85016
    United States

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    Little Rock, Arkansas 72209
    United States

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    Anaheim, California 92805
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    Bellflower, California 90706
    United States

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    Beverly Hills, California 90210
    United States

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    Colton, California 92324
    United States

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    Costa Mesa, California 92627
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    Culver City, California 90230
    United States

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    Encino, California 91316
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    Glendale, California 91206
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    Imperial, California 92251
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    Lancaster, California 93534
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    Los Alamitos, California 90720
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    Los Angeles, California 90024
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    Sherman Oaks, California 91403
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    Stanford, California 94305
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    Hartford, Connecticut 06106
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    New Haven, Connecticut 06519
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    New London, Connecticut 06320
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    Norwich, Connecticut 06360
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    Apopka, Florida 32703
    United States

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    Boca Raton, Florida 33431
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    Coral Gables, Florida 33134
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    Coral Springs, Florida 33067
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    Fort Myers, Florida 33912
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    Gainesville, Florida 32606
    United States

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    Hialeah, Florida 33016
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    Hialeah, Florida 33010
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    Hialeah, Florida 33013
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    Jacksonville, Florida 90024
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    Lauderhill, Florida 33319
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    Lutz, Florida 33548
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    Maitland, Florida 32751
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    Miami, Florida 33125
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    Miami, Florida 33135
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    Miami, Florida 33175
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    Miami, Florida 33173
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    Miami, Florida 33174
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    Miami, Florida 33165
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    Miami, Florida 33176
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    Miami, Florida 33157
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    Miami Gardens, Florida 33014
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    Miami Springs, Florida 33166
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    Naples, Florida 34102
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    New Port Richey, Florida 34655
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    North Bay Village, Florida 33141
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    North Miami, Florida 33161
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    North Miami Beach, Florida 33162
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    Orange City, Florida 32763
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    Orlando, Florida 32803
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    Orlando, Florida 32807
    United States

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    Orlando, Florida 32808
    United States

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    Palmetto Bay, Florida 33157
    United States

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    Pembroke Pines, Florida 33026
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    Sweetwater, Florida 33172
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    Winter Park, Florida 32789
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    Atlanta, Georgia 30328
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    Decatur, Georgia 30030
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    Snellville, Georgia 30078
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    Chicago, Illinois 91786
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    Chicago, Illinois 60640
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    Elgin, Illinois 60123
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    Naperville, Illinois 60563
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    Prairie Village, Kansas 66208
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    New Orleans, Louisiana 70115
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    Bangor, Maine 04401
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    Gaithersburg, Maryland 20877
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    Pikesville, Maryland 21208
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    Towson, Maryland 21204
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    Boston, Massachusetts 02131
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    Boston, Massachusetts 02114
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    Methuen, Massachusetts 01844
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    Springfield, Massachusetts 01103
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    Watertown, Massachusetts 02472
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    Ann Arbor, Michigan 48105
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    Flowood, Mississippi 39232
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    O'Fallon, Missouri 63368
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    Saint Louis, Missouri 63128
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    Missoula, Montana 59804
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    Las Vegas, Nevada 89102
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    Berlin, New Jersey 08009
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    Cherry Hill, New Jersey 08002
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  • Bio Behavioral Health

    Toms River, New Jersey 08755
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    Brooklyn, New York 11229
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    Brooklyn, New York 11235
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    Cedarhurst, New York 11516
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    Great Neck, New York 11021
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    Mount Kisco, New York 10549
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    New York, New York 10019
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    New York, New York 10036
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    New York, New York 10032
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    Rochester, New York 14618
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    Staten Island, New York 10312
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    Fayetteville, North Carolina 28303
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    Beavercreek, Ohio 45431
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    Canton, Ohio 44718
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    Cincinnati, Ohio 45212
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    Dayton, Ohio 45417
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    Oklahoma City, Oklahoma 73106
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    Tulsa, Oklahoma 74136
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  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania 18104
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    Media, Pennsylvania 19063
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    Philadelphia, Pennsylvania 19104
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    Mount Pleasant, South Carolina 29464
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  • BioBehavioral Research of Austin

    Austin, Texas 78759
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    Baytown, Texas 77521
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    Bryan, Texas 77802
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  • FutureSearch Trials of Dallas, LP

    Dallas, Texas 75231
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    Dallas, Texas 75243
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    DeSoto, Texas 75115
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    Fort Worth, Texas 76104
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    Houston, Texas 77030
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    Houston, Texas 77074
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    Houston, Texas 77081
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    Mesquite, Texas 75149
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    Missouri City, Texas 77459
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    Plano, Texas 75093
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    San Antonio, Texas 78229
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    Wichita Falls, Texas 76309
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    Woodstock, Vermont 05091
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    Bellevue, Washington 98007
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