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

NCT03299166 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BHV4157-202
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 57

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score

  The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.

  Baseline, Week 12

Secondary Outcomes (6)

• Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase

  Up to 12 weeks

• Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the Open-Label Extension Phase

  Up to 192 weeks

• Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase

  Up to 12 weeks

• Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score

  Baseline, Week 12

• Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score

  Baseline, Week 12

Other Outcomes (1)

• Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8

  Baseline, Week 4 and Week 8

Study Arms (2)

Troriluzole

EXPERIMENTAL

Drug: Troriluzole

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Matching capsule once daily (QD)

Placebo

Troriluzole 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

Troriluzole

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 the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
• Participants must be currently experiencing non-response or inadequate response to their current standard of care (SOC) medication defined as:
• Participant Yale-Brown Obsessive Compulsive Scale total score must be ≥ 19 at screening and Baseline, reflecting moderate or severe OCD symptoms.
• Participants must currently be on a SSRI, clomipramine, venlafaxine or desvenlafaxine.
• 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;
• Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;
• Participants must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
• 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;
• 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).
• WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline;
• 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).
• The duration of the subject's OCD disease was to be ≥ 1 year.
• In addition, subjects had to be on stable doses of other psychotropic medication for at least 12 weeks prior to screening.
• Subjects had to have a Clinical Global Impression of Severity Scale (CGI-S) score of ≥ 4 at screening and baseline.

You may not qualify if:

• 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:
• 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;
• Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine, venlafaxine, or desvenlafaxine
• Adequate dose: Defined by the the United States Prescribing Information labeling.
• 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
• Mini Mental State Examination (MMSE) score of \< 24 at Screening
• 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;
• Any eating disorder within the last 12 months;
• Acute suicidality or suicide attempt or self-injurious behavior in the last 6 months;
• History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).
• Transcranial Magnetic Stimulation (TMS) is prohibited within 3 months prior to screening and during the study.
• 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.
• Creatinine ≥ 2 mg/dL.
• Course of treatment for participants with localized cancers (without metastatic spread) is 5 years prior to screening.
• 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.

Sponsors & Collaborators

• Biohaven Pharmaceuticals, Inc.: lead

Study Sites (57)

Metropolitan Neuro Behavioral Institute

Chandler, Arizona, 85226, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Synergy Research San Diego

Lemon Grove, California, 91945, United States

Location

CalNeuro Research Group

Los Angeles, California, 90024, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94607, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

Desert Valley Research

Rancho Mirage, California, 92270, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Artemis Institute for Clinical Research

San Marcos, California, 92078, United States

Location

Stanford University, Department of Psychiatry and Behavioral Sciences

Stanford, California, 94305-5717, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Mountain View Clinical Research, Inc.

Denver, Colorado, 80209, United States

Location

Institute of Living / Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, 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

Galiz Research

Hialeah, Florida, 33016, United States

Location

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, 32256, United States

Location

SIH Research, Inc

Kissimmee, Florida, 34741, United States

Location

Harmony Clinical Research

North Miami Beach, Florida, 33162, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

iResearch Savannah

Savannah, Georgia, 31405, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, 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

Phoenix Medical Research, Inc.

Prairie Village, Kansas, 66208, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Pharmasite Research, Inc.

Pikesville, Maryland, 21208, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Michigan Clinical Research PC

Ann Arbor, Michigan, 48105, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

ActivMed Practices and Research, Inc.

Portsmouth, New Hampshire, 03801, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08028, United States

Location

Integrative Clinical Trials LLC

Brooklyn, New York, 11229, United States

Location

Bio Behavioral Institute

Great Neck, New York, 11021, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

FutureSearch Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Psychiatric Alliance of the Blue Ridge, Inc.

Charlottesville, Virginia, 22903, 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

Limitations and Caveats

The provided results are from the DB Randomization Phase as the Open-Label Extension phase is still on-going.

Results Point of Contact

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

clinicaltrials@biohavenpharma.com

203-404-0410

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 28, 2017
• First Posted: October 2, 2017
• Study Start: December 19, 2017
• Primary Completion: June 2, 2020
• Study Completion: December 8, 2025
• Last Updated: January 22, 2026
• Results First Posted: June 2, 2023

Record last verified: 2026-01

Locations

US (57)