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

February 23, 2026 updated by: Biohaven Pharmaceuticals, Inc.

A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

772

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University Of Calgary
    • Ontario
      • Chatham, Ontario, Canada, N7L 1C1
        • Chatham-Kent Clinical Trials Research Centre
      • Hamilton, Ontario, Canada, L8S 1B7
        • McMaster University, Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 5G2
        • Queen's University
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M4W 2N4
        • START Clinic for Mood and Anxiety Disorders
      • Toronto, Ontario, Canada, M6J 1H4
        • University of Toronto / Centre for Addiction and Mental Health (CAMH)
  • Italy
      • Florence, Italy, 50121
        • Institute of Neuroscience, University of Firenze
      • Milan, Italy, 20157
        • ASST FBF SACCO - Ospedale Universitario Luigi Sacco
      • Naples, Italy, 80131
        • University School of Medicine of Napoli Federico II
      • Pisa, Italy, 56126
        • University of Pisa
      • Turin, Italy, 10043
        • University of Turin - university hospital san luigi gonzaga
  • Netherlands
      • Amsterdam, Netherlands, 1100
        • Amsterdam UMC, locatie AMC
      • Leiden, Netherlands, 2333
        • Leiden University Medical Center (LUMC)
  • Spain
      • Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Oviedo, Spain, 33011
        • Centro de Salud Mental La Corredoria
      • Salamanca, Spain, 37005
        • Centro de Salud San Juan
      • Vigo, Spain, 36312
        • Hospital Alvaro Cunqueiro
  • United Kingdom
      • Blackpool, United Kingdom, FY2 0JH
        • MAC Clinical Research-Lancashire
      • Chertsey, United Kingdom, KT16 0AE
        • Surrey and Borders Partnership NHS Foundation Trust
      • Liverpool, United Kingdom, L34 1BH
        • MAC Clinical Research -- Merseyside
      • London, United Kingdom, SW17 7DJ
        • South West London and St George's Mental Health NHS Trust Springfield University Hospital
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research-Greater Manchester
      • Manchester, United Kingdom, M25 3BL
        • Greater Manchester Mental Health NHS Foundation Trust
      • Milton Keynes, United Kingdom, MK15 0DU
        • Bioluminux Ltd
      • Tankersley, United Kingdom, S75 3DL
        • MAC Clinical Research-- South Yorkshire
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Metropolitan Neuro Behavioral Institute
      • Phoenix, Arizona, United States, 85012
        • Alea Research
      • Phoenix, Arizona, United States, 85016
        • NoeisisPharma, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72209
        • Atria Clinical Research
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Bellflower, California, United States, 90706
        • CITrials (Clinical Innovations)
      • Beverly Hills, California, United States, 90210
        • Southern California Research, LLC
      • Colton, California, United States, 92324
        • Axiom Research, LLC
      • Costa Mesa, California, United States, 92627
        • Global Clinical Trials
      • Culver City, California, United States, 90230
        • Proscience Research Group
      • Encino, California, United States, 91316
        • WR-PRI, LLC (Encino)
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • Imperial, California, United States, 92251
        • Sun Valley Research Center, Inc.
      • Lancaster, California, United States, 93534
        • OM Research LLC
      • Lemon Grove, California, United States, 91945
        • Synergy Research San Diego
      • Long Beach, California, United States, 90807
        • Alliance for Research
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Los Angeles, California, United States, 90024
        • CalNeuro Research Group
      • Los Angeles, California, United States, 90064
        • Clarity Clinical Research
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute (WR-PRI, LLC)
      • Oakland, California, United States, 94607
        • Pacific Research Partners
      • Oceanside, California, United States, 92054
        • North County Clinical Research
      • Oceanside, California, United States, 92056
        • Excell Research, Inc
      • Orange, California, United States, 92688
        • Nrc Research Institute
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • Riverside, California, United States, 92506
        • CI Trials
      • San Diego, California, United States, 92119
        • ACRC Studies
      • San Jose, California, United States, 95124
        • Lumos Clinical Research Center, LLC
      • Santa Ana, California, United States, 92704
        • National Research Institute
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc
      • Stanford, California, United States, 94305
        • Stanford University
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Research
      • Upland, California, United States, 91786
        • Pacific Clinical Research Medical Group
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Institute of Living / Hartford Hospital
      • New Haven, Connecticut, United States, 06519
        • Yale University
      • New London, Connecticut, United States, 06320
        • Coastal Connecticut Research, LLC
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Apopka, Florida, United States, 32703
        • Topaz Clinical Research
      • Boca Raton, Florida, United States, 33431
        • Boca Raton Medical Institute
      • Coral Gables, Florida, United States, 33134
        • Advanced Clinical Research Network
      • Coral Springs, Florida, United States, 33067
        • CNS Research of Coral Springs
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Clinical Research Center
      • Gainesville, Florida, United States, 32606
        • University of Florida Department of Psychiatry
      • Hialeah, Florida, United States, 33010
        • Qway Research, LLC
      • Hialeah, Florida, United States, 33016
        • Galiz Research
      • Hialeah, Florida, United States, 33013
        • Research in Miami Inc
      • Hialeah, Florida, United States, 33015
        • Health Care Family Rehab & Research
      • Jacksonville, Florida, United States, 90024
        • Clinical Neuroscience Solutions, Inc
      • Lakeland, Florida, United States, 33803
        • Accel Research Sites (formerly Meridien Research)
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, Inc.
      • Lutz, Florida, United States, 33548
        • Pharmaceutical Research Center, Inc.
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Maitland, Florida, United States, 32751
        • ClinCloud, LLC
      • Miami, Florida, United States, 33176
        • Miami Dade Medical Research Institute
      • Miami, Florida, United States, 33165
        • Med-Care Research
      • Miami, Florida, United States, 33174
        • Florida Research Center, Inc.
      • Miami, Florida, United States, 33157
        • Sanchez Clinical Research Inc
      • Miami, Florida, United States, 33125
        • Central Miami Medical Institute
      • Miami, Florida, United States, 33135
        • Clintex Research
      • Miami, Florida, United States, 33173
        • FIRC
      • Miami, Florida, United States, 33175
        • Ezy Medical Research, Co.
      • Miami Gardens, Florida, United States, 33014
        • Pro-Care Research Center
      • Miami Springs, Florida, United States, 33166
        • South Florida Research Phase I-IV, Inc.
      • Naples, Florida, United States, 34102
        • Advanced Research for Health Improvement
      • New Port Richey, Florida, United States, 34655
        • Bayside Clinical Research, LLC
      • North Bay Village, Florida, United States, 33141
        • Bravo Health Care Center
      • North Miami, Florida, United States, 33161
        • Behavioral Clinical Research
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, United States, 32803
        • Apg Research, Llc
      • Orlando, Florida, United States, 32808
        • Omega Research Consultants
      • Orlando, Florida, United States, 32807
        • Combined Research Orlando Phase I-Iv
      • Palmetto Bay, Florida, United States, 33157
        • IMIC Inc
      • Pembroke Pines, Florida, United States, 33026
        • MedBio Trials
      • Pinellas Park, Florida, United States, 33782
        • DMI Research
      • Sweetwater, Florida, United States, 33172
        • LENUS Research & Medical Group, LLC
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • Tampa, Florida, United States, 33614
        • Olympian Clinical Research
      • Winter Park, Florida, United States, 32789
        • Conquest Research LLC
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Neurotrials Research Inc
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Savannah, Georgia, United States, 31405
        • iResearch Savannah
      • Snellville, Georgia, United States, 30078
        • Renew Health Clinical Research, LLC
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research Institute
      • Chicago, Illinois, United States, 91786
        • University of Chicago Department of Psychiatry & Behavioral Neuroscience
      • Elgin, Illinois, United States, 60123
        • Revive Research Institute
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
      • Naperville, Illinois, United States, 60563
        • AMR-Baber Research, Inc
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Collective Medical Research
    • Maine
      • Bangor, Maine, United States, 04401
        • Northern Light Acadia Hospital
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
      • Pikesville, Maryland, United States, 21208
        • Pharmasite Research, Inc.
      • Towson, Maryland, United States, 21204
        • Continental Clinical Solutions, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices and Research
      • Springfield, Massachusetts, United States, 01103
        • Sisu at RMG
      • Watertown, Massachusetts, United States, 02472
        • Adams Clinical
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Michigan Clinical Research Institute PC
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Psychiatric Care and Research Center
      • St Louis, Missouri, United States, 63128
        • PsychCare Consultants Research
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
      • Cherry Hill, New Jersey, United States, 08002
        • Center For Emotional Fitness
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials, Llc
      • Brooklyn, New York, United States, 11235
        • SPRI Clinical Trials, LLC
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc
      • Great Neck, New York, United States, 11021
        • Bio Behavioral Institute
      • Mount Kisco, New York, United States, 10549
        • Bioscience Research, LLC
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute
      • New York, New York, United States, 10036
        • Manhattan Behavioral Medicine, PLLC
      • New York, New York, United States, 10019
        • Hapworth Research
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Fayetteville, North Carolina, United States, 28303
        • Carolina Institute for Clinical Research
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Clinical Inquest Center, LTD
      • Canton, Ohio, United States, 44718
        • NeuroScience Research Center, LLC.
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • IPS Research
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research, LLC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center For Clinical Research
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Texas
      • Austin, Texas, United States, 78759
        • BioBehavioral Research of Austin
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc. (DRI)
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • Dallas, Texas, United States, 75243
        • Relaro Medical Trials
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Fort Worth, Texas, United States, 76104
        • North Texas Clinical Trials
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research
      • Missouri City, Texas, United States, 77459
        • Mt.Olympus Medical Research LLC
      • Plano, Texas, United States, 75093
        • AIM Trials
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • Wichita Falls, Texas, United States, 76309
        • Grayline Research Center
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Woodstock Research Center
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.
  • Determined by the investigator to be medically stable at the week 10 visit of BHV4157-302 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 sexually active agree to use two methods of contraception for the duration of the study

Key Exclusion Criteria:

  • Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.
  • Acute suicidality or suicide attempt or self injurious behavior in the last 12 months.
  • Patients who may have received a non-biological investigational agent in any clinical 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Troriluzole (BHV-4157)
200 mg daily first 2 weeks, 280 daily following first 2 weeks
Drug: Troriluzole (BHV-4157)
200 mg daily first 2 weeks, 280 daily following first 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment
Time Frame: Change from Baseline to week 240
Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.
Change from Baseline to week 240

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biohaven Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Actual)

February 13, 2026

Study Completion (Actual)

February 13, 2026

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV4157-209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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