Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

NCT ID: NCT04641143

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2025-10-27

Brief Summary

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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)

Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Troriluzole

Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.

Group Type ACTIVE_COMPARATOR

Troriluzole

Intervention Type DRUG

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

Placebo

Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Troriluzole

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biohaven Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Metropolitan Neuro Behavioral Institute

Chandler, Arizona, United States

Site Status

IMA Clinical Research

Phoenix, Arizona, United States

Site Status

NoeisisPharma, LLC

Phoenix, Arizona, United States

Site Status

CITrials (Clinical Innovations)

Bellflower, California, United States

Site Status

Axiom Research, LLC

Colton, California, United States

Site Status

WR-PRI, LLC (Encino)

Encino, California, United States

Site Status

Behavioral Research Specialists, LLC

Glendale, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Clarity Clinical Research

Los Angeles, California, United States

Site Status

Excell Research, Inc

Oceanside, California, United States

Site Status

NRC Research Institute

Orange, California, United States

Site Status

Anderson Clinical Research

Redlands, California, United States

Site Status

Lumos Clinical Research Center, LLC

San Jose, California, United States

Site Status

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Collaborative Neuroscience Research

Torrance, California, United States

Site Status

Yale University / Connecticut Mental Health Center

New Haven, Connecticut, United States

Site Status

Comprehensive Psychiatric Care

Norwich, Connecticut, United States

Site Status

Boca Raton Medical Institute

Boca Raton, Florida, United States

Site Status

Advanced Clinical Research Network

Coral Gables, Florida, United States

Site Status

Research in Miami Inc

Hialeah, Florida, United States

Site Status

Accel Research Sites

Lakeland, Florida, United States

Site Status

Innovative Clinical Research, Inc.

Lauderhill, Florida, United States

Site Status

Health Care Family Rehab & Research

Miami, Florida, United States

Site Status

Central Miami Medical Institute

Miami, Florida, United States

Site Status

FIRC

Miami, Florida, United States

Site Status

Florida Research Center, Inc.

Miami, Florida, United States

Site Status

South Florida Research Phase I-IV , Inc.

Miami Springs, Florida, United States

Site Status

Behavioral Clinical Research

North Miami, Florida, United States

Site Status

Medical Research Group of Central Florida

Orange City, Florida, United States

Site Status

APG Research, LLC

Orlando, Florida, United States

Site Status

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

Site Status

Omega Research Consultants

Orlando, Florida, United States

Site Status

MedBio Trials

Pembroke Pines, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

Neurobehaviorial Institute

Weston, Florida, United States

Site Status

Conquest Research LLC

Winter Park, Florida, United States

Site Status

iResearch Atlanta, LLC

Decatur, Georgia, United States

Site Status

iResearch Savannah

Savannah, Georgia, United States

Site Status

Northwest Clinical Trials

Boise, Idaho, United States

Site Status

Uptown Research Institute

Chicago, Illinois, United States

Site Status

Revive Research Institute

Elgin, Illinois, United States

Site Status

AMR-Baber Research, Inc

Naperville, Illinois, United States

Site Status

Collective Medical Research

Overland Park, Kansas, United States

Site Status

CBH Health

Gaithersburg, Maryland, United States

Site Status

Pharmasite Research, Inc.

Pikesville, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston Clinical Trials

Boston, Massachusetts, United States

Site Status

ActivMed Practices and Research

Methuen, Massachusetts, United States

Site Status

Sisu at RMG

Springfield, Massachusetts, United States

Site Status

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

Site Status

Precise Research Centers

Flowood, Mississippi, United States

Site Status

Psychiatric Care and Research Center

O'Fallon, Missouri, United States

Site Status

Altea Research

Las Vegas, Nevada, United States

Site Status

Hassman Research Institute

Berlin, New Jersey, United States

Site Status

Bio Behavioral Health

Toms River, New Jersey, United States

Site Status

Integrative Clinical Trials, LLC

Brooklyn, New York, United States

Site Status

Neurobehavioral Research, Inc

Cedarhurst, New York, United States

Site Status

Bio Behavioral Institute

Great Neck, New York, United States

Site Status

Bioscience Research, LLC

Mount Kisco, New York, United States

Site Status

Manhattan Behavioral Medicine, PLLC

New York, New York, United States

Site Status

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status

Clinical Inquest Center, Ltd

Beavercreek, Ohio, United States

Site Status

Central States Research, LLC

Tulsa, Oklahoma, United States

Site Status

Suburban Research Associates

Media, Pennsylvania, United States

Site Status

Comprehensive Psychiatric Care Providers

Providence, Rhode Island, United States

Site Status

BioBehavioral Research of Austin

Austin, Texas, United States

Site Status

Relaro Medical Trials

Dallas, Texas, United States

Site Status

North Texas Clinical Trials

Fort Worth, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Site Status

Mt.Olympus Medical Research LLC

Missouri City, Texas, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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BHV4157-302

Identifier Type: -

Identifier Source: org_study_id

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