ClinicalTrials.gg
TerminatedNCT04708834Updated Feb 25, 2026

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

A Phase 3 interventional study of Troriluzole (BHV-4157) in Obsessive Compulsive Disorder, sponsored by Biohaven Pharmaceuticals, Inc.. Terminated at 175 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Biohaven Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated
Sponsor Decision
Phase
Phase 3
Study type
Interventional
Enrollment
772
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

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).

02

Conditions studied

  • Obsessive Compulsive Disorder

Keywords

  • Obsessive compulsive disorder
  • OCD
  • troriluzole
  • Biohaven
03

In context

Obsessive-Compulsive Disorder

635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.

This study's enrollment of 772 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

Biohaven Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 6 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 testing.
  • It is required that all women of (WOCBP) who are sexually active agree to use two methods of 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 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;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
772 participants (actual)

Study arms

  • Experimental
    Troriluzole (BHV-4157)

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

    Drug: Troriluzole (BHV-4157)

Interventions

06

What researchers measure

Primary outcomes

  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.

    Time frame: Change from Baseline to week 240

07

Study locations

175 sites
  • Metropolitan Neuro Behavioral Institute
    Chandler, Arizona 85226, United States
  • Alea Research
    Phoenix, Arizona 85012, United States
  • NoeisisPharma, LLC
    Phoenix, Arizona 85016, United States
  • Atria Clinical Research
    Little Rock, Arkansas 72209, United States
  • Advanced Research Center, Inc.
    Anaheim, California 92805, United States
  • CITrials (Clinical Innovations)
    Bellflower, California 90706, United States
  • Southern California Research, LLC
    Beverly Hills, California 90210, United States
  • Axiom Research, LLC
    Colton, California 92324, United States
  • Global Clinical Trials
    Costa Mesa, California 92627, United States
  • ProScience Research Group
    Culver City, California 90230, United States
  • WR-PRI, LLC (Encino)
    Encino, California 91316, United States
  • Behavioral Research Specialists, LLC
    Glendale, California 91206, United States
  • Sun Valley Research Center, Inc.
    Imperial, California 92251, United States
  • Om Research LLC
    Lancaster, California 93534, United States
  • Synergy Research San Diego
    Lemon Grove, California 91945, United States
  • Alliance for Research
    Long Beach, California 90807, United States
  • Pharmacology Research Institute
    Los Alamitos, California 90720, United States
  • CalNeuro Research Group
    Los Angeles, California 90024, United States
  • Clarity Clinical Research
    Los Angeles, California 90064, United States
  • Pharmacology Research Institute (WR-PRI, LLC)
    Newport Beach, California 92660, United States
  • Pacific Research Partners
    Oakland, California 94607, United States
  • North County Clinical Research
    Oceanside, California 92054, United States
  • Excell Research, Inc
    Oceanside, California 92056, United States
  • NRC Research Institute
    Orange, California 92688, United States
  • Anderson Clinical Research
    Redlands, California 92374, United States
  • CI Trials
    Riverside, California 92506, United States
  • ACRC Studies
    San Diego, California 92119, United States
  • Lumos Clinical Research Center, LLC
    San Jose, California 95124, United States
  • National Research Institute
    Santa Ana, California 92704, United States
  • California Neuroscience Research Medical Group, Inc
    Sherman Oaks, California 91403, United States
  • Stanford University
    Stanford, California 94305, United States
  • Collaborative Neuroscience Research
    Torrance, California 90502, United States
  • Pacific Clinical Research Medical Group
    Upland, California 91786, United States
  • Mountain View Clinical Research
    Denver, Colorado 80209, United States
  • Institute of Living / Hartford Hospital
    Hartford, Connecticut 06106, United States
  • Yale University
    New Haven, Connecticut 06519, United States
  • Coastal Connecticut Research, LLC
    New London, Connecticut 06320, United States
  • Comprehensive Psychiatric Care
    Norwich, Connecticut 06360, United States
  • Topaz Clinical Research
    Apopka, Florida 32703, United States
  • Boca Raton Medical Institute
    Boca Raton, Florida 33431, United States
  • Advanced Clinical Research Network
    Coral Gables, Florida 33134, United States
  • CNS Research of Coral Springs
    Coral Springs, Florida 33067, United States
  • Gulfcoast Clinical Research Center
    Fort Myers, Florida 33912, United States
  • University of Florida Department of Psychiatry
    Gainesville, Florida 32606, United States
  • Qway Research, LLC
    Hialeah, Florida 33010, United States
  • Research in Miami Inc
    Hialeah, Florida 33013, United States
  • Health Care Family Rehab & Research
    Hialeah, Florida 33015, United States
  • Galiz Research
    Hialeah, Florida 33016, United States
  • Clinical Neuroscience Solutions, Inc
    Jacksonville, Florida 90024, United States
  • Accel Research Sites (formerly Meridien Research)
    Lakeland, Florida 33803, United States
  • Innovative Clinical Research, Inc.
    Lauderhill, Florida 33319, United States
  • Pharmaceutical Research Center, Inc.
    Lutz, Florida 33548, United States
  • ClinCloud, LLC
    Maitland, Florida 32751, United States
  • Meridien Research
    Maitland, Florida 32751, United States
  • Central Miami Medical Institute
    Miami, Florida 33125, United States
  • Clintex Research
    Miami, Florida 33135, United States
  • Sanchez Clinical Research Inc
    Miami, Florida 33157, United States
  • Med-Care Research
    Miami, Florida 33165, United States
  • FIRC
    Miami, Florida 33173, United States
  • Florida Research Center, Inc.
    Miami, Florida 33174, United States
  • Ezy Medical Research, Co.
    Miami, Florida 33175, United States
  • Miami Dade Medical Research Institute
    Miami, Florida 33176, United States
  • Pro-Care Research Center
    Miami Gardens, Florida 33014, United States
  • South Florida Research Phase I-IV, Inc.
    Miami Springs, Florida 33166, United States
  • Advanced Research for Health Improvement
    Naples, Florida 34102, United States
  • Bayside Clinical Research, LLC
    New Port Richey, Florida 34655, United States
  • Bravo Health Care Center
    North Bay Village, Florida 33141, United States
  • Behavioral Clinical Research
    North Miami, Florida 33161, United States
  • Harmony Clinical Research
    North Miami Beach, Florida 33162, United States
  • Medical Research Group of Central Florida
    Orange City, Florida 32763, United States
  • APG Research, LLC
    Orlando, Florida 32803, United States
  • Combined Research Orlando Phase I-IV
    Orlando, Florida 32807, United States
  • Omega Research Consultants
    Orlando, Florida 32808, United States
  • IMIC Inc
    Palmetto Bay, Florida 33157, United States
  • MedBio Trials
    Pembroke Pines, Florida 33026, United States
  • DMI Research
    Pinellas Park, Florida 33782, United States
  • Lenus Research & Medical Group, LLC
    Sweetwater, Florida 33172, United States
  • Stedman Clinical Trials
    Tampa, Florida 33613, United States
  • Olympian Clinical Research
    Tampa, Florida 33614, United States
  • Conquest Research LLC
    Winter Park, Florida 32789, United States
  • NeuroTrials Research Inc
    Atlanta, Georgia 30328, United States
  • iResearch Atlanta, LLC
    Decatur, Georgia 30030, United States
  • iResearch Savannah
    Savannah, Georgia 31405, United States
  • Renew Health Clinical Research, LLC
    Snellville, Georgia 30078, United States
  • Northwest Clinical Trials
    Boise, Idaho 83704, United States
  • Uptown Research Institute
    Chicago, Illinois 60640, United States
  • University of Chicago Department of Psychiatry & Behavioral Neuroscience
    Chicago, Illinois 91786, United States
  • Revive Research Institute
    Elgin, Illinois 60123, United States
  • Capstone Clinical Research
    Libertyville, Illinois 60048, United States
  • AMR-Baber Research, Inc
    Naperville, Illinois 60563, United States
  • Collective Medical Research
    Prairie Village, Kansas 66208, United States
  • Northern Light Acadia Hospital
    Bangor, Maine 04401, United States
  • CBH Health
    Gaithersburg, Maryland 20877, United States
  • Pharmasite Research, Inc.
    Pikesville, Maryland 21208, United States
  • Continental Clinical Solutions, LLC
    Towson, Maryland 21204, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Boston Clinical Trials
    Boston, Massachusetts 02131, United States
  • ActivMed Practices and Research
    Methuen, Massachusetts 01844, United States
  • Sisu at RMG
    Springfield, Massachusetts 01103, United States
  • Adams Clinical
    Watertown, Massachusetts 02472, United States

Showing the first 100 of 175 sites across 6 countries. Choose a country and city above to see the rest.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Feb 2026, 58 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2021
First posted
Jan 14, 2021
StartActual
Mar 30, 2021
Primary completionActual
Feb 13, 2026
CompletionActual
Feb 13, 2026
Last update
Feb 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04708834
Lead sponsor
Biohaven Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jan 14, 2021
Start date
Mar 30, 2021
Primary completion
Feb 13, 2026
Completion
Feb 13, 2026
Last update
Feb 25, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Troriluzole

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