Troriluzole (BHV-4157) in Adult Participants With Obsessive Compulsive Disorder

NCT ID: NCT03299166

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2025-12-08

Brief Summary

The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder (OCD) who had an inadequate response to selective serotonin reuptake inhibitor (SSRI), clomipramine, venlafaxine, or desvenlafaxine treatment

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Troriluzole

Group Type: EXPERIMENTAL

Troriluzole

Intervention Type: DRUG

Troriluzole, 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching capsule once daily (QD)

Interventions

Troriluzole

Troriluzole, 140 mg capsules once daily (QD) orally for the first 4 weeks and 200 mg (140 mg+ 60 mg capsules QD) for an additional 8 weeks

Intervention Type: DRUG

Placebo

Matching capsule once daily (QD)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Primary diagnosis of OCD as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).

2. Participants must be currently experiencing non-response or inadequate response to their current standard of care (SOC) medication defined as:

1. Participant Yale-Brown Obsessive Compulsive Scale total score must be ≥ 19 at screening and Baseline, reflecting moderate or severe OCD symptoms.

2. Participants must currently be on a SSRI, clomipramine, venlafaxine or desvenlafaxine.

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 trial as designed;

4. Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;

5. Participants must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;

6. Participants must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications;

7. It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study (i.e. beginning 30 days prior to baseline and extending to 30 days after the last dose of study drug).

8. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline;

9. It is required that men who are sexually active with WOCBP agree to use 2 methods of contraception for the duration of the study (beginning at first treatment and extending to 90 days after the last dose of study drug).

10. The duration of the subject's OCD disease was to be ≥ 1 year.

11. In addition, subjects had to be on stable doses of other psychotropic medication for at least 12 weeks prior to screening.

12. Subjects had to have a Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at screening and baseline.

Exclusion Criteria

1. Participants should be excluded with a history of more than 2 previous failed treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine (not including the current SSRI trial) given for an adequate duration at an adequate dose as defined by the following criteria taken from the Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD) as follows:

1. Treatment failure / non-response: As per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the participant despite an adequate dose and duration of treatment;

2. Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine, venlafaxine, or desvenlafaxine

3. Adequate dose: Defined by the the United States Prescribing Information labeling.

2. Evidence at screening or baseline of any medical or psychiatric condition other than OCD that could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of OCD symptoms

3. Mini Mental State Examination (MMSE) score of < 24 at Screening

4. Current or prior history, per DSM-5 criteria, of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's disorder is also excluded;

5. Any eating disorder within the last 12 months;

6. Acute suicidality or suicide attempt or self-injurious behavior in the last 6 months;

7. History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).

8. Transcranial Magnetic Stimulation (TMS) is prohibited within 3 months prior to screening and during the study.

9. Participants who may have received a non-biological investigational agent in any clinical trial within 30 days, or a biological agent within 90 days prior to screening are excluded.

10. Creatinine ≥ 2 mg/dL.

11. Course of treatment for participants with localized cancers (without metastatic spread) is 5 years prior to screening.

12. QTcF (Fridericia) interval ≥ 470 msec during the screening or baseline period or uncontrolled arrhythmia or frequent premature ventricular contraction (PVCs) (> 5/minute) or Mobitz Type II second or third degree atrioventricular (AV) block or left bundle branch block, or right bundle branch block with a QRS duration ≥ 150 msec or intraventricular conduction defect with a QRS duration ≥150 msec or evidence of acute or sub-acute myocardial infarction or ischemia and added or other electrocardiogram findings that, in the investigator's opinion, would preclude participation in the study.

13. Previous treatment with riluzole

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biohaven Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Metropolitan Neuro Behavioral Institute

Chandler, Arizona, United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Collaborative Neuroscience Network, LLC

Garden Grove, California, United States

University of California San Diego

La Jolla, California, United States

Synergy Research San Diego

Lemon Grove, California, United States

CalNeuro Research Group

Los Angeles, California, United States

Pacific Research Partners, LLC

Oakland, California, United States

NRC Research Institute

Orange, California, United States

Desert Valley Research

Rancho Mirage, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Artemis Institute for Clinical Research

San Marcos, California, United States

Stanford University, Department of Psychiatry and Behavioral Sciences

Stanford, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Mountain View Clinical Research, Inc.

Denver, Colorado, United States

Institute of Living / Hartford Hospital

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Comprehensive Psychiatric Care

Norwich, Connecticut, United States

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

University of Florida Department of Psychiatry

Gainesville, Florida, United States

Galiz Research

Hialeah, Florida, United States

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, United States

SIH Research, Inc

Kissimmee, Florida, United States

Harmony Clinical Research

North Miami Beach, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

iResearch Atlanta, LLC

Decatur, Georgia, United States

iResearch Savannah

Savannah, Georgia, United States

Chicago Research Center

Chicago, Illinois, United States

University of Chicago Department of Psychiatry & Behavioral Neuroscience

Chicago, Illinois, United States

AMR-Baber Research, Inc

Naperville, Illinois, United States

Phoenix Medical Research, Inc.

Prairie Village, Kansas, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Pharmasite Research, Inc.

Pikesville, Maryland, United States

McLean Hospital

Belmont, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Michigan Clinical Research PC

Ann Arbor, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire, United States

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Integrative Clinical Trials LLC

Brooklyn, New York, United States

Bio Behavioral Institute

Great Neck, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

New Horizons Clinical Research

Cincinnati, Ohio, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Summit Research Network (Oregon) Inc.

Portland, Oregon, United States

Suburban Research Associates

Media, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

FutureSearch Trials of Dallas, LP

Dallas, Texas, United States

InSite Clinical Research

DeSoto, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Psychiatric Alliance of the Blue Ridge, Inc.

Charlottesville, Virginia, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BHV4157-202

Identifier Type: -

Identifier Source: org_study_id