Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

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: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Drug: Troriluzole; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 456
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)	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

Outcome Measure	Measure Description	Time Frame
Frequency of SAEs and AEs leading to discontinuation	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)	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.	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

• Sponsor: Biohaven Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): October 27, 2025
• Study Completion (Actual): October 27, 2025

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: OCD; Obsessive-Compulsive Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID 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