AzTrials
AzTrials

Obsessive Compulsive DisorderPhase 3NCT04708834

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

A Phase 3 study testing Troriluzole (BHV-4157) in people with Obsessive Compulsive Disorder, run by Biohaven Pharmaceuticals, Inc. at 175 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obsessive Compulsive Disorder
What is being tested?
Troriluzole (BHV-4157)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
772 participants
Where
175 sitesin 6 countries
Study dates
30 Mar 2021to 13 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;

Trial locations and contacts

175 sites in 6 countries.

175 sites in 6 countries

United States147 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Advanced Research Center, Inc.

    Anaheim, California, 92805

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan, 48105

  • Topaz Clinical Research

    Apopka, Florida, 32703

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30328

  • BioBehavioral Research of Austin

    Austin, Texas, 78759

  • Northern Light Acadia Hospital

    Bangor, Maine, 04401

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Clinical Inquest Center, Ltd

    Beavercreek, Ohio, 45431

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • CITrials (Clinical Innovations)

    Bellflower, California, 90706

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Southern California Research, LLC

    Beverly Hills, California, 90210

  • Boca Raton Medical Institute

    Boca Raton, Florida, 33431

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Integrative Clinical Trials, LLC

    Brooklyn, New York, 11229

  • SPRI Clinical Trials, LLC

    Brooklyn, New York, 11235

  • DiscoveResearch, Inc. (DRI)

    Bryan, Texas, 77802

  • NeuroScience Research Center, LLC.

    Canton, Ohio, 44718

  • Neurobehavioral Research, Inc

    Cedarhurst, New York, 11516

  • Metropolitan Neuro Behavioral Institute

    Chandler, Arizona, 85226

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Uptown Research Institute

    Chicago, Illinois, 60640

  • University of Chicago Department of Psychiatry & Behavioral Neuroscience

    Chicago, Illinois, 91786

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Axiom Research, LLC

    Colton, California, 92324

  • Advanced Clinical Research Network

    Coral Gables, Florida, 33134

  • CNS Research of Coral Springs

    Coral Springs, Florida, 33067

  • Global Clinical Trials

    Costa Mesa, California, 92627

  • ProScience Research Group

    Culver City, California, 90230

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Relaro Medical Trials

    Dallas, Texas, 75243

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Mountain View Clinical Research

    Denver, Colorado, 80209

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Revive Research Institute

    Elgin, Illinois, 60123

  • WR-PRI, LLC (Encino)

    Encino, California, 91316

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • North Texas Clinical Trials

    Fort Worth, Texas, 76104

  • University of Florida Department of Psychiatry

    Gainesville, Florida, 32606

  • CBH Health

    Gaithersburg, Maryland, 20877

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • Bio Behavioral Institute

    Great Neck, New York, 11021

  • Institute of Living / Hartford Hospital

    Hartford, Connecticut, 06106

  • Qway Research, LLC

    Hialeah, Florida, 33010

  • Research in Miami Inc

    Hialeah, Florida, 33013

  • Health Care Family Rehab & Research

    Hialeah, Florida, 33015

  • Galiz Research

    Hialeah, Florida, 33016

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Clinical Trial Network

    Houston, Texas, 77074

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Sun Valley Research Center, Inc.

    Imperial, California, 92251

  • Clinical Neuroscience Solutions, Inc

    Jacksonville, Florida, 90024

  • Accel Research Sites (formerly Meridien Research)

    Lakeland, Florida, 33803

  • Om Research LLC

    Lancaster, California, 93534

  • Altea Research

    Las Vegas, Nevada, 89102

  • Innovative Clinical Research, Inc.

    Lauderhill, Florida, 33319

  • Synergy Research San Diego

    Lemon Grove, California, 91945

  • Capstone Clinical Research

    Libertyville, Illinois, 60048

  • Atria Clinical Research

    Little Rock, Arkansas, 72209

  • Alliance for Research

    Long Beach, California, 90807

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • CalNeuro Research Group

    Los Angeles, California, 90024

  • Clarity Clinical Research

    Los Angeles, California, 90064

  • Pharmaceutical Research Center, Inc.

    Lutz, Florida, 33548

  • ClinCloud, LLC

    Maitland, Florida, 32751

  • Meridien Research

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • Central Miami Medical Institute

    Miami, Florida, 33125

  • Clintex Research

    Miami, Florida, 33135

  • Sanchez Clinical Research Inc

    Miami, Florida, 33157

  • Med-Care Research

    Miami, Florida, 33165

  • FIRC

    Miami, Florida, 33173

  • Florida Research Center, Inc.

    Miami, Florida, 33174

  • Ezy Medical Research, Co.

    Miami, Florida, 33175

  • Miami Dade Medical Research Institute

    Miami, Florida, 33176

  • Pro-Care Research Center

    Miami Gardens, Florida, 33014

  • South Florida Research Phase I-IV, Inc.

    Miami Springs, Florida, 33166

  • Boeson Research

    Missoula, Montana, 59804

  • Mt.Olympus Medical Research LLC

    Missouri City, Texas, 77459

  • Bioscience Research, LLC

    Mount Kisco, New York, 10549

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • AMR-Baber Research, Inc

    Naperville, Illinois, 60563

  • Advanced Research for Health Improvement

    Naples, Florida, 34102

  • Yale University

    New Haven, Connecticut, 06519

  • Coastal Connecticut Research, LLC

    New London, Connecticut, 06320

  • Bayside Clinical Research, LLC

    New Port Richey, Florida, 34655

  • Hapworth Research

    New York, New York, 10019

  • New York State Psychiatric Institute

    New York, New York, 10032

  • Manhattan Behavioral Medicine, PLLC

    New York, New York, 10036

  • Pharmacology Research Institute (WR-PRI, LLC)

    Newport Beach, California, 92660

  • Bravo Health Care Center

    North Bay Village, Florida, 33141

  • Behavioral Clinical Research

    North Miami, Florida, 33161

  • Harmony Clinical Research

    North Miami Beach, Florida, 33162

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360

  • Psychiatric Care and Research Center

    O'Fallon, Missouri, 63368

  • Pacific Research Partners

    Oakland, California, 94607

  • North County Clinical Research

    Oceanside, California, 92054

  • Excell Research, Inc

    Oceanside, California, 92056

  • IPS Research

    Oklahoma City, Oklahoma, 73106

  • NRC Research Institute

    Orange, California, 92688

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • APG Research, LLC

    Orlando, Florida, 32803

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807

  • Omega Research Consultants

    Orlando, Florida, 32808

  • IMIC Inc

    Palmetto Bay, Florida, 33157

  • MedBio Trials

    Pembroke Pines, Florida, 33026

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Alea Research

    Phoenix, Arizona, 85012

  • NoeisisPharma, LLC

    Phoenix, Arizona, 85016

  • Pharmasite Research, Inc.

    Pikesville, Maryland, 21208

  • DMI Research

    Pinellas Park, Florida, 33782

  • AIM Trials

    Plano, Texas, 75093

  • Collective Medical Research

    Prairie Village, Kansas, 66208

  • Anderson Clinical Research

    Redlands, California, 92374

  • CI Trials

    Riverside, California, 92506

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • ACRC Studies

    San Diego, California, 92119

  • Lumos Clinical Research Center, LLC

    San Jose, California, 95124

  • National Research Institute

    Santa Ana, California, 92704

  • iResearch Savannah

    Savannah, Georgia, 31405

  • California Neuroscience Research Medical Group, Inc

    Sherman Oaks, California, 91403

  • Renew Health Clinical Research, LLC

    Snellville, Georgia, 30078

  • Sisu at RMG

    Springfield, Massachusetts, 01103

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Stanford University

    Stanford, California, 94305

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Lenus Research & Medical Group, LLC

    Sweetwater, Florida, 33172

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Olympian Clinical Research

    Tampa, Florida, 33614

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Collaborative Neuroscience Research

    Torrance, California, 90502

  • Continental Clinical Solutions, LLC

    Towson, Maryland, 21204

  • Central States Research, LLC

    Tulsa, Oklahoma, 74136

  • Pacific Clinical Research Medical Group

    Upland, California, 91786

  • Adams Clinical

    Watertown, Massachusetts, 02472

  • Grayline Research Center

    Wichita Falls, Texas, 76309

  • Conquest Research LLC

    Winter Park, Florida, 32789

  • Woodstock Research Center

    Woodstock, Vermont, 05091

Other trials in United States

United Kingdom8 sites

  • MAC Clinical Research-Lancashire

    Blackpool, FY2 0JH

  • Surrey and Borders Partnership NHS Foundation Trust

    Chertsey, KT16 0AE

  • MAC Clinical Research -- Merseyside

    Liverpool, L34 1BH

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

    London, SW17 7DJ

  • MAC Clinical Research-Greater Manchester

    Manchester, M13 9NQ

  • Greater Manchester Mental Health NHS Foundation Trust

    Manchester, M25 3BL

  • Bioluminux Ltd

    Milton Keynes, MK15 0DU

  • MAC Clinical Research-- South Yorkshire

    Tankersley, S75 3DL

Other trials in United Kingdom

Canada7 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Chatham-Kent Clinical Trials Research Centre

    Chatham, Ontario, N7L 1C1

  • McMaster University, Hamilton Health Sciences

    Hamilton, Ontario, L8S 1B7

  • Queen's University

    Kingston, Ontario, K7L 5G2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • START Clinic for Mood and Anxiety Disorders

    Toronto, Ontario, M4W 2N4

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

    Toronto, Ontario, M6J 1H4

Other trials in Canada

Spain6 sites

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Centro de Salud Mental La Corredoria

    Oviedo, 33011

  • Centro de Salud San Juan

    Salamanca, 37005

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Italy5 sites

  • Institute of Neuroscience, University of Firenze

    Florence, 50121

  • ASST FBF SACCO - Ospedale Universitario Luigi Sacco

    Milan, 20157

  • University School of Medicine of Napoli Federico II

    Naples, 80131

  • University of Pisa

    Pisa, 56126

  • University of Turin - university hospital san luigi gonzaga

    Turin, 10043

Other trials in Italy

Netherlands2 sites

  • Amsterdam UMC, locatie AMC

    Amsterdam, 1100

  • Leiden University Medical Center (LUMC)

    Leiden, 2333

Other trials in Netherlands

About this study

Official title: 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).

Being tested
Troriluzole (BHV-4157)
Keywords
Obsessive compulsive disorder, OCD, troriluzole, Biohaven
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Troriluzole (BHV-4157)Drug

    200 mg daily first 2 weeks, 280 daily following first 2 weeks

Study groups in NCT04708834
Study groupRoleWhat they receive
Troriluzole (BHV-4157)Experimental200 mg daily first 2 weeks, 280 daily following first 2 weeks
Receives: Drug: Troriluzole (BHV-4157)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.

    Measured: Change from Baseline to week 240

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2021
  2. Study start30 Mar 2021
  3. Primary completion13 Feb 2026
  4. Study completion13 Feb 2026

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
772 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04708834
Sponsor's protocol ID
BHV4157-209
Status last verified
Feb 2026
First submitted
11 Jan 2021
Last updated
25 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Troriluzole (BHV-4157) in people with Obsessive Compulsive Disorder, run by Biohaven Pharmaceuticals, Inc. at 175 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, United Kingdom, Canada, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04708834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in