Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

January 5, 2026 updated by: Biohaven Pharmaceuticals, Inc.

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85284
        • Metropolitan Neuro Behavioral Institute
      • Phoenix, Arizona, United States, 85016
        • NoeisisPharma, LLC
      • Phoenix, Arizona, United States, 85012
        • IMA Clinical Research
    • California
      • Bellflower, California, United States, 90706
        • CITrials (Clinical Innovations)
      • Colton, California, United States, 92324
        • Axiom Research, LLC
      • Encino, California, United States, 91316
        • WR-PRI, LLC (Encino)
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Los Angeles, California, United States, 90064
        • Clarity 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
      • San Jose, California, United States, 95124
        • Lumos Clinical Research Center, LLC
      • 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
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University / Connecticut Mental Health Center
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Boca Raton Medical Institute
      • Coral Gables, Florida, United States, 33134
        • Advanced Clinical Research Network
      • Hialeah, Florida, United States, 33013
        • Research in Miami Inc
      • Lakeland, Florida, United States, 33803
        • Accel Research Sites
      • Lauderhill, Florida, United States, 33319
        • Innovative Clinical Research, Inc.
      • Miami, Florida, United States, 33174
        • Florida Research Center, Inc.
      • Miami, Florida, United States, 33125
        • Central Miami Medical Institute
      • Miami, Florida, United States, 33173
        • FIRC
      • Miami, Florida, United States, 33015
        • Health Care Family Rehab & Research
      • Miami Springs, Florida, United States, 33166
        • South Florida Research Phase I-IV , Inc.
      • North Miami, Florida, United States, 33161
        • Behavioral 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
      • Pembroke Pines, Florida, United States, 33026
        • MedBio Trials
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • Weston, Florida, United States, 33326
        • Neurobehaviorial Institute
      • Winter Park, Florida, United States, 32789
        • Conquest Research LLC
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Savannah, Georgia, United States, 31405
        • iResearch Savannah
    • Idaho
      • Boise, Idaho, United States, 83704
        • Northwest Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research Institute
      • Elgin, Illinois, United States, 60123
        • Revive Research Institute
      • Naperville, Illinois, United States, 60563
        • AMR-Baber Research, Inc
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Collective Medical Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
      • Pikesville, Maryland, United States, 21208
        • Pharmasite Research, Inc.
    • 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
    • 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
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative 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, 10036
        • Manhattan Behavioral Medicine, PLLC
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Clinical Inquest Center, LTD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research, LLC
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Comprehensive Psychiatric Care Providers
    • Texas
      • Austin, Texas, United States, 78759
        • BioBehavioral Research of Austin
      • Dallas, Texas, United States, 75243
        • Relaro Medical Trials
      • 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.
      • Missouri City, Texas, United States, 77459
        • Mt.Olympus Medical Research LLC
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year
  2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
  3. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed

Exclusion Criteria:

  1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
  2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results
  3. Previous treatment in a study with troriluzole

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Troriluzole
Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.
Drug: Troriluzole
Troriluzole - 2 100mg capsules QD for the first two weeks.
Placebo Comparator: Placebo
Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
Drug: Placebo
Matching placebo - 2 140mg capsules QD from week two through week ten.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10
Improvement is measured by a lower total score
Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of SAEs and AEs leading to discontinuation
Time Frame: From Screening through study completion, up to 10 weeks
Percent difference between troriluzole vs placebo treatment emergent adverse events.
From Screening through study completion, up to 10 weeks
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)
Time Frame: From baseline through study completion (up to 10 weeks)
Change is measured as "mild" or "moderate" on the SDS
From baseline through study completion (up to 10 weeks)
Improvement in global functioning responses assessed on the CGI-I scale.
Time Frame: From baseline through study completion (up to 10 weeks)
Change is measured as "much improved" or "very much improved" on the CGII scale
From baseline through study completion (up to 10 weeks)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BHV4157-302

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings