Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

NCT04641143 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: BHV4157-302
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 73

Brief 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)

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; OCD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Frequency of SAEs and AEs leading to discontinuation

  From Screening through study completion, up to 10 weeks

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

  From baseline through study completion (up to 10 weeks)

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

  From baseline through study completion (up to 10 weeks)

Study Arms (2)

Troriluzole

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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 DRUG

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

Troriluzole

Placebo DRUG

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

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 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
• 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
• 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

You may not qualify if:

• 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.
• 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
• Previous treatment in a study with troriluzole

Sponsors & Collaborators

• Biohaven Pharmaceuticals, Inc.: lead

Study Sites (73)

Metropolitan Neuro Behavioral Institute

Chandler, Arizona, 85284, United States

Location

IMA Clinical Research

Phoenix, Arizona, 85012, United States

Location

NoeisisPharma, LLC

Phoenix, Arizona, 85016, United States

Location

CITrials (Clinical Innovations)

Bellflower, California, 90706, United States

Location

Axiom Research, LLC

Colton, California, 92324, United States

Location

WR-PRI, LLC (Encino)

Encino, California, 91316, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Clarity Clinical Research

Los Angeles, California, 90064, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

NRC Research Institute

Orange, California, 92688, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

Lumos Clinical Research Center, LLC

San Jose, California, 95124, United States

Location

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, 91403, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Collaborative Neuroscience Research

Torrance, California, 90502, United States

Location

Yale University / Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Boca Raton Medical Institute

Boca Raton, Florida, 33431, United States

Location

Advanced Clinical Research Network

Coral Gables, Florida, 33134, United States

Location

Research in Miami Inc

Hialeah, Florida, 33013, United States

Location

Accel Research Sites

Lakeland, Florida, 33803, United States

Location

Innovative Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Health Care Family Rehab & Research

Miami, Florida, 33015, United States

Location

Central Miami Medical Institute

Miami, Florida, 33125, United States

Location

FIRC

Miami, Florida, 33173, United States

Location

Florida Research Center, Inc.

Miami, Florida, 33174, United States

Location

South Florida Research Phase I-IV , Inc.

Miami Springs, Florida, 33166, United States

Location

Behavioral Clinical Research

North Miami, Florida, 33161, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

APG Research, LLC

Orlando, Florida, 32803, United States

Location

Combined Research Orlando Phase I-IV

Orlando, Florida, 32807, United States

Location

Omega Research Consultants

Orlando, Florida, 32808, United States

Location

MedBio Trials

Pembroke Pines, Florida, 33026, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Neurobehaviorial Institute

Weston, Florida, 33326, United States

Location

Conquest Research LLC

Winter Park, Florida, 32789, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

iResearch Savannah

Savannah, Georgia, 31405, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Revive Research Institute

Elgin, Illinois, 60123, United States

Location

AMR-Baber Research, Inc

Naperville, Illinois, 60563, United States

Location

Collective Medical Research

Overland Park, Kansas, 66210, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Pharmasite Research, Inc.

Pikesville, Maryland, 21208, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

ActivMed Practices and Research

Methuen, Massachusetts, 01844, United States

Location

Sisu at RMG

Springfield, Massachusetts, 01103, United States

Location

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, 48105, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

Altea Research

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Integrative Clinical Trials, LLC

Brooklyn, New York, 11229, United States

Location

Neurobehavioral Research, Inc

Cedarhurst, New York, 11516, United States

Location

Bio Behavioral Institute

Great Neck, New York, 11021, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Manhattan Behavioral Medicine, PLLC

New York, New York, 10036, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Clinical Inquest Center, Ltd

Beavercreek, Ohio, 45431, United States

Location

Central States Research, LLC

Tulsa, Oklahoma, 74136, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Comprehensive Psychiatric Care Providers

Providence, Rhode Island, 02906, United States

Location

BioBehavioral Research of Austin

Austin, Texas, 78759, United States

Location

Relaro Medical Trials

Dallas, Texas, 75243, United States

Location

North Texas Clinical Trials

Fort Worth, Texas, 76104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Mt.Olympus Medical Research LLC

Missouri City, Texas, 77459, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

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: November 12, 2020
• First Posted: November 23, 2020
• Study Start: December 22, 2020
• Primary Completion: October 27, 2025
• Study Completion: October 27, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (73)