A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive Disorder

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

The purpose of this study was to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in participants with Obsessive Compulsive Disorder (OCD).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 589
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
  • Ontario
    • Chatham, Ontario, Canada, N7L 1C1
      • Chatham-Kent Clinical Trials Research Centre
    • Hamilton, Ontario, Canada, L8S 1B7
      • McMaster University, Hamilton Health Sciences
    • Kingston, Ontario, Canada, K7L 5G2
      • Queen's University
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M4W 2N4
      • START Clinic for Mood and Anxiety Disorders
    • Toronto, Ontario, Canada, M6J 1H4
      • University of Toronto / Centre for Addiction and Mental Health (CAMH)
• China
  • Changping District
    • Beijing, Changping District, China, 100085
      • Beijing HuiLongGuan Hospital
  • Haidian District
    • Beijing, Haidian District, China, 100083
      • Peking University Sixth Hospital
  • Hangzhou City
    • Hangzhou, Hangzhou City, China, 310063
      • Hangzhou Seventh People's Hospital
  • Hexi District
    • Tianjin, Hexi District, China, 300222
      • Tianjin Anding Hospital
  • Hunan
    • Xiangya, Hunan, China, 410008
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Brain Hospital
  • Minhang District
    • Shanghai, Minhang District, China, 201108
      • Shanghai Mental Health Center
  • Qiaokou District
    • Wuhan, Qiaokou District, China, 430022
      • Wuhan Mental Health Center
  • Tianhe District
    • Guangzhou, Tianhe District, China, 510660
      • The First Affiliated Hospital of Jinan University
  • Wuhou District
    • Chengdu, Wuhou District, China, 610041
      • Mental Health Center, West China Hospital, Sichuan University
  • Yuhua District
    • Shijiazhuang, Yuhua District, China, 050001
      • First Hospital of Hebei Medical University
• Italy
  • Milan, Italy, 20157
    • ASST FBF SACCO - Ospedale Universitario Luigi Sacco
  • Naples, Italy, 80131
    • University School of Medicine of Napoli Federico II
  • Pisa, Italy, 56126
    • University of Pisa
  • Turin, Italy, 10043
    • University of Turin - university hospital san luigi gonzaga
• Netherlands
  • Amsterdam, Netherlands, 1100
    • Amsterdam UMC, locatie AMC
  • Leiden, Netherlands, 2333
    • Leiden University Medical Center (LUMC)
• Spain
  • Barcelona, Spain, 08907
    • Hospital Universitario de Bellvitge
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Oviedo, Spain, 33011
    • Centro de Salud Mental La Corredoria
  • Salamanca, Spain, 37005
    • Centro de Salud San Juan
  • Vigo, Spain, 36312
    • Hospital Álvaro Cunqueiro
• United Kingdom
  • Blackpool, United Kingdom, FY2 0JH
    • MAC Clinical Research-Lancashire
  • Leeds, United Kingdom, LS10 1DU
    • MAC Clinical Research
  • Liverpool, United Kingdom, L34 1BH
    • MAC Clinical Research -- Merseyside
  • Manchester, United Kingdom, M25 3BL
    • Greater Manchester Mental Health NHS Foundation Trust
  • Milton Keynes, United Kingdom, MK15 0DU
    • Bioluminux Ltd
  • Swindon, United Kingdom, SN3 6BW
    • Kingshill Research Centre
  • Tankersley, United Kingdom, S75 3DL
    • MAC Clinical Research-- South Yorkshire
  • County Durham
    • Stockton-on-Tees, County Durham, United Kingdom, TS17 6EW
      • MAC Clinical Research
  • Northamptonshire
    • Stony Stratford, Northamptonshire, United Kingdom, MK19 6FG
      • Stemax Consult - Healthcare Services Ltd
  • South Staffordshire
    • Cannock, South Staffordshire, United Kingdom, WS11 0BN
      • MAC Clinical Research - South Staffordshire
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Alea Research
  • California
    • Culver City, California, United States, 90230
      • ProScience Research Group
    • La Jolla, California, United States, 92037
      • Kaizen Brain Center
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Los Angeles, California, United States, 90024
      • CalNeuro Research Group
    • San Jose, California, United States, 95124
      • Lumos Clinical Research Center, LLC
    • Santa Ana, California, United States, 92704
      • Velocity Clinical Research
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
    • Upland, California, United States, 91786
      • Pacific Clinical Research Medical Group
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Care
  • Florida
    • Apopka, Florida, United States, 32703
      • Topaz Clinical Research
    • Coral Springs, Florida, United States, 33067
      • CNS Research of Coral Springs
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Gainesville, Florida, United States, 32606
      • University of Florida Department of Psychiatry
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Miami, Florida, United States, 33165
      • Med-Care Research
    • Miami, Florida, United States, 33175
      • Ezy Medical Research, Co.
    • Naples, Florida, United States, 34102
      • Advanced Research for Health Improvement
    • North Miami Beach, Florida, United States, 33162
      • Harmony Clinical Research
    • Palm Beach, Florida, United States, 33480
      • dTMS Center LLC
    • Pinellas Park, Florida, United States, 33782
      • DMI Research
  • Georgia
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch
    • Snellville, Georgia, United States, 30078
      • Renew Health Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Department of Psychiatry & Behavioral Neuroscience
    • Naperville, Illinois, United States, 60563
      • AMR-Baber Research, Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Collective Medical Research
  • Maryland
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
  • Missouri
    • O'Fallon, Missouri, United States, 63368
      • Psychiatric Care and Research Center
  • Montana
    • Missoula, Montana, United States, 59804
      • Boeson Research
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08028
      • Center For Emotional Fitness
  • New York
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • New York, New York, United States, 10036
      • Manhattan Behavioral Medicine, PLLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Richard H. Weisler, MD PA & Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research Center
    • Dayton, Ohio, United States, 45432
      • American Clinical Research Institute (ACRI)
    • Kettering, Ohio, United States, 45439
      • American Research Institute (ACRI)
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia Jr., MD PA
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Plano, Texas, United States, 75093
      • AIM Trials
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Woodstock Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening; the duration of the participants illness must be ≥ 1year
2. An inadequate response to current standard of care (SOC) 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 US Package Insert [USPI] labelling); an inadequate response to current SOC based on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score.
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. Participants must be physically able and expected to complete the trail as designed.

Key Exclusion Criteria:

1. Participants 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 Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD).
2. Current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism 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
Experimental: Troriluzole; Participants received troriluzole 200 milligrams (mg) (100 mg*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase.	Drug: Troriluzole; Capsules for oral administration.
Placebo Comparator: Placebo; Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.	Drug: Placebo; Drug- matching capsules for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)	Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.	Baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An Adverse event (AE) was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, that did not necessarily have a causal relationship with treatment. An AE could be any unfavourable/unintended sign including an abnormal laboratory finding, symptom/disease temporally associated with the use of the study drug, whether or not considered related to it. A TEAE was defined as any AE that developed, worsened, or became serious after first dose of test treatment	From first dose up to approximately 12 weeks
Change From Baseline in Sheehan Disability Scale (SDS) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8	The SDS was a participant-rated measure of functional disability. SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Higher scores indicated a more severe impairment.	Baseline and Week 8
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Total Score in the Baseline Y-BOCS ≥24 Stratification Cohort at Week 8	The CGI-S was a clinician rated assessment of the participants current illness state on a 7-point scale. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicated a more severe illness.	Baseline and Week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Y-BOCS Total Score in the Baseline Y-BOCS = 22 or 23 Stratification Cohort at Week 8 (Negative Change Indicates Symptom Improvement)	Y-BOCS was a clinician-administered instrument used to assess the severity of obsessive compulsive disorder (OCD) symptoms and to monitor treatment response. The scale included 10 items: 5 items assessed obsessions and 5 items assessed compulsions. Each item was rated from 0 to 4, generating an obsessions subscale score (0-20), a compulsions subscale score (0-20), and a total score ranging from 0 to 40. Higher scores indicated greater OCD symptom severity. Negative change (or reduction in score) indicates improvement.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Biohaven Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obsessive-Compulsive Disorder (OCD)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: BHV4157-303; 2024-514585-39-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No