ClinicalTrials.gg
CompletedNCT04641143Updated Jan 7, 2026

Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

A Phase 3 interventional study of Troriluzole and Placebo in Obsessive-Compulsive Disorder, sponsored by Biohaven Pharmaceuticals, Inc.. Completed at 73 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

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

From the registry’s dates

  • Primary completion was Oct 2025, 1 year ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
456
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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)

02

Conditions studied

  • Obsessive-Compulsive Disorder

Keywords

  • Obsessive-Compulsive Disorder
  • OCD
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 456 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per , 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 testing. Subjects must be physically able and expected to complete the trial as designed

Exclusion criteria

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
Terms in these criteria, in plain language(2)

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.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
456 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Troriluzole - 2 100mg capsules QD for the first two weeks.

  • DrugPlacebo

    Matching placebo - 2 140mg capsules QD from week two through week ten.

06

What researchers measure

Primary outcomes

  1. The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Improvement is measured by a lower total score

    Time frame: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10

Secondary outcomes

  1. Frequency of SAEs and AEs leading to discontinuation

    Percent difference between troriluzole vs placebo treatment emergent adverse events.

    Time frame: From Screening through study completion, up to 10 weeks

  2. Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)

    Change is measured as "mild" or "moderate" on the SDS

    Time frame: From baseline through study completion (up to 10 weeks)

  3. Improvement in global functioning responses assessed on the CGI-I scale.

    Change is measured as "much improved" or "very much improved" on the CGII scale

    Time frame: From baseline through study completion (up to 10 weeks)

07

Study locations

73 sites
  • Metropolitan Neuro Behavioral Institute
    Chandler, Arizona 85284, United States
  • IMA Clinical Research
    Phoenix, Arizona 85012, United States
  • NoeisisPharma, LLC
    Phoenix, Arizona 85016, United States
  • CITrials (Clinical Innovations)
    Bellflower, California 90706, United States
  • Axiom Research, LLC
    Colton, California 92324, United States
  • WR-PRI, LLC (Encino)
    Encino, California 91316, United States
  • Behavioral Research Specialists, LLC
    Glendale, California 91206, United States
  • Pharmacology Research Institute
    Los Alamitos, California 90720, United States
  • Clarity Clinical Research
    Los Angeles, California 90064, 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
  • Lumos Clinical Research Center, LLC
    San Jose, California 95124, 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
  • Yale University / Connecticut Mental Health Center
    New Haven, Connecticut 06519, United States
  • Comprehensive Psychiatric Care
    Norwich, Connecticut 06360, United States
  • Boca Raton Medical Institute
    Boca Raton, Florida 33431, United States
  • Advanced Clinical Research Network
    Coral Gables, Florida 33134, United States
  • Research in Miami Inc
    Hialeah, Florida 33013, United States
  • Accel Research Sites
    Lakeland, Florida 33803, United States
  • Innovative Clinical Research, Inc.
    Lauderhill, Florida 33319, United States
  • Health Care Family Rehab & Research
    Miami, Florida 33015, United States
  • Central Miami Medical Institute
    Miami, Florida 33125, United States
  • FIRC
    Miami, Florida 33173, United States
  • Florida Research Center, Inc.
    Miami, Florida 33174, United States
  • South Florida Research Phase I-IV , Inc.
    Miami Springs, Florida 33166, United States
  • Behavioral Clinical Research
    North Miami, Florida 33161, 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
  • MedBio Trials
    Pembroke Pines, Florida 33026, United States
  • Stedman Clinical Trials
    Tampa, Florida 33613, United States
  • Neurobehaviorial Institute
    Weston, Florida 33326, United States
  • Conquest Research LLC
    Winter Park, Florida 32789, United States
  • iResearch Atlanta, LLC
    Decatur, Georgia 30030, United States
  • iResearch Savannah
    Savannah, Georgia 31405, United States
  • Northwest Clinical Trials
    Boise, Idaho 83704, United States
  • Uptown Research Institute
    Chicago, Illinois 60640, United States
  • Revive Research Institute
    Elgin, Illinois 60123, United States
  • AMR-Baber Research, Inc
    Naperville, Illinois 60563, United States
  • Collective Medical Research
    Overland Park, Kansas 66210, United States
  • CBH Health
    Gaithersburg, Maryland 20877, United States
  • Pharmasite Research, Inc.
    Pikesville, Maryland 21208, 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
  • Michigan Clinical Research Institute PC
    Ann Arbor, Michigan 48105, United States
  • Precise Research Centers
    Flowood, Mississippi 39232, United States
  • Psychiatric Care and Research Center
    O'Fallon, Missouri 63368, United States
  • Altea Research
    Las Vegas, Nevada 89102, United States
  • Hassman Research Institute
    Berlin, New Jersey 08009, United States
  • Bio Behavioral Health
    Toms River, New Jersey 08755, United States
  • Integrative Clinical Trials, LLC
    Brooklyn, New York 11229, United States
  • Neurobehavioral Research, Inc
    Cedarhurst, New York 11516, United States
  • Bio Behavioral Institute
    Great Neck, New York 11021, United States
  • Bioscience Research, LLC
    Mount Kisco, New York 10549, United States
  • Manhattan Behavioral Medicine, PLLC
    New York, New York 10036, United States
  • Richmond Behavioral Associates
    Staten Island, New York 10312, United States
  • Clinical Inquest Center, Ltd
    Beavercreek, Ohio 45431, United States
  • Central States Research, LLC
    Tulsa, Oklahoma 74136, United States
  • Suburban Research Associates
    Media, Pennsylvania 19063, United States
  • Comprehensive Psychiatric Care Providers
    Providence, Rhode Island 02906, United States
  • BioBehavioral Research of Austin
    Austin, Texas 78759, United States
  • Relaro Medical Trials
    Dallas, Texas 75243, United States
  • North Texas Clinical Trials
    Fort Worth, Texas 76104, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Texas Center for Drug Development, Inc.
    Houston, Texas 77081, United States
  • Mt.Olympus Medical Research LLC
    Missouri City, Texas 77459, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98007, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04641143
Lead sponsor
Biohaven Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Nov 23, 2020
Start date
Dec 22, 2020
Primary completion
Oct 27, 2025
Completion
Oct 27, 2025
Last update
Jan 7, 2026

Oversight

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

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

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Studies of the drug tested here: Troriluzole

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