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

NCT04693351 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: BHV4157-3032024-514585-39-00
• Study Type: interventional
• Target: 589
• Locations: 7 countries
• Sites: 89

Brief Summary

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).

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  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

  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

  Baseline and Week 8

Other Outcomes (1)

• 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)

  Baseline and Week 8

Study Arms (2)

Troriluzole

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.

Drug: Placebo

Interventions

Troriluzole DRUG

Capsules for oral administration.

Troriluzole

Placebo DRUG

Drug- matching capsules for oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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.

You may not qualify if:

• 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).
• 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.
• Previous treatment in a study with troriluzole.

Sponsors & Collaborators

• Biohaven Pharmaceuticals, Inc.: lead

Study Sites (89)

Alea Research

Phoenix, Arizona, 85012, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Kaizen Brain Center

La Jolla, California, 92037, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

CalNeuro Research Group

Los Angeles, California, 90024, United States

Location

Lumos Clinical Research Center, LLC

San Jose, California, 95124, United States

Location

Velocity Clinical Research

Santa Ana, California, 92704, United States

Location

California Neuroscience Research Medical Group, Inc.

Sherman Oaks, California, 91403, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Topaz Clinical Research

Apopka, Florida, 32703, United States

Location

CNS Research of Coral Springs

Coral Springs, Florida, 33067, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

University of Florida Department of Psychiatry

Gainesville, Florida, 32606, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Med-Care Research

Miami, Florida, 33165, United States

Location

Ezy Medical Research, Co.

Miami, Florida, 33175, United States

Location

Advanced Research for Health Improvement

Naples, Florida, 34102, United States

Location

Harmony Clinical Research

North Miami Beach, Florida, 33162, United States

Location

dTMS Center LLC

Palm Beach, Florida, 33480, United States

Location

DMI Research

Pinellas Park, Florida, 33782, United States

Location

CenExel iResearch

Decatur, Georgia, 30030, United States

Location

Renew Health Clinical Research, LLC

Snellville, Georgia, 30078, United States

Location

University of Chicago Department of Psychiatry & Behavioral Neuroscience

Chicago, Illinois, 60637, United States

Location

AMR-Baber Research, Inc.

Naperville, Illinois, 60563, United States

Location

Collective Medical Research

Overland Park, Kansas, 66210, United States

Location

Continental Clinical Solutions, LLC

Towson, Maryland, 21204, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08028, United States

Location

SPRI Clinical Trials, LLC

Brooklyn, New York, 11235, United States

Location

Manhattan Behavioral Medicine, PLLC

New York, New York, 10036, United States

Location

Richard H. Weisler, MD PA & Associates

Raleigh, North Carolina, 27609, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

American Clinical Research Institute (ACRI)

Dayton, Ohio, 45432, United States

Location

American Research Institute (ACRI)

Kettering, Ohio, 45439, United States

Location

North Star Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Donald J. Garcia Jr., MD PA

Austin, Texas, 78737, United States

Location

Inquest Clinical Research

Baytown, Texas, 77521, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

AIM Trials

Plano, Texas, 75093, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Woodstock Research Center

Woodstock, Vermont, 05091, United States

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, N7L 1C1, Canada

Location

McMaster University, Hamilton Health Sciences

Hamilton, Ontario, L8S 1B7, Canada

Location

Queen's University

Kingston, Ontario, K7L 5G2, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

START Clinic for Mood and Anxiety Disorders

Toronto, Ontario, M4W 2N4, Canada

Location

University of Toronto / Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, M6J 1H4, Canada

Location

Beijing HuiLongGuan Hospital

Beijing, Changping District, 100085, China

Location

Peking University Sixth Hospital

Beijing, Haidian District, 100083, China

Location

Hangzhou Seventh People's Hospital

Hangzhou, Hangzhou City, 310063, China

Location

Tianjin Anding Hospital

Tianjin, Hexi District, 300222, China

Location

The Second Xiangya Hospital of Central South University

Xiangya, Hunan, 410008, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

Shanghai Mental Health Center

Shanghai, Minhang District, 201108, China

Location

Wuhan Mental Health Center

Wuhan, Qiaokou District, 430022, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Tianhe District, 510660, China

Location

Mental Health Center, West China Hospital, Sichuan University

Chengdu, Wuhou District, 610041, China

Location

First Hospital of Hebei Medical University

Shijiazhuang, Yuhua District, 050001, China

Location

ASST FBF SACCO - Ospedale Universitario Luigi Sacco

Milan, 20157, Italy

Location

University School of Medicine of Napoli Federico II

Naples, 80131, Italy

Location

University of Pisa

Pisa, 56126, Italy

Location

University of Turin - university hospital san luigi gonzaga

Turin, 10043, Italy

Location

Amsterdam UMC, locatie AMC

Amsterdam, 1100, Netherlands

Location

Leiden University Medical Center (LUMC)

Leiden, 2333, Netherlands

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Centro de Salud Mental La Corredoria

Oviedo, 33011, Spain

Location

Centro de Salud San Juan

Salamanca, 37005, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, 36312, Spain

Location

MAC Clinical Research

Stockton-on-Tees, County Durham, TS17 6EW, United Kingdom

Location

Stemax Consult - Healthcare Services Ltd

Stony Stratford, Northamptonshire, MK19 6FG, United Kingdom

Location

MAC Clinical Research - South Staffordshire

Cannock, South Staffordshire, WS11 0BN, United Kingdom

Location

MAC Clinical Research-Lancashire

Blackpool, FY2 0JH, United Kingdom

Location

MAC Clinical Research

Leeds, LS10 1DU, United Kingdom

Location

MAC Clinical Research -- Merseyside

Liverpool, L34 1BH, United Kingdom

Location

Greater Manchester Mental Health NHS Foundation Trust

Manchester, M25 3BL, United Kingdom

Location

Bioluminux Ltd

Milton Keynes, MK15 0DU, United Kingdom

Location

Kingshill Research Centre

Swindon, SN3 6BW, United Kingdom

Location

MAC Clinical Research-- South Yorkshire

Tankersley, S75 3DL, United Kingdom

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Biohaven Pharmaceuticals, Inc.

clinicaltrials@biohavenpharma.com

+12034040410

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: January 29, 2021
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); GB (10); ES (6); CA (7); CN (11); IT (4); US (49)