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

August 28, 2023 updated by: Biohaven Pharmaceuticals, Inc.

A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

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

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

426

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Chandler, Arizona, United States, 85226
        • Metropolitan Neuro Behavioral Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc.
    • California
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, LLC
      • La Jolla, California, United States, 92037
        • University of California San Diego
      • Lemon Grove, California, United States, 91945
        • Synergy Research San Diego
      • Los Angeles, California, United States, 90024
        • CalNeuro Research Group
      • Oakland, California, United States, 94607
        • Pacific Research Partners, LLC
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Rancho Mirage, California, United States, 92270
        • Desert Valley Research
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • San Marcos, California, United States, 92078
        • Artemis Institute for Clinical Research
      • Stanford, California, United States, 94305-5717
        • Stanford University, Department of Psychiatry and Behavioral Sciences
      • Upland, California, United States, 91786
        • Pacific Clinical Research Medical Group
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research, Inc.
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Institute of Living / Hartford Hospital
      • New Haven, Connecticut, United States, 06519
        • Yale University
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Clinical Research Center
      • Gainesville, Florida, United States, 32606
        • University of Florida Department of Psychiatry
      • Hialeah, Florida, United States, 33016
        • Galiz Research
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc
      • Kissimmee, Florida, United States, 34741
        • SIH Research, Inc
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc
    • Georgia
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Savannah, Georgia, United States, 31405
        • iResearch Savannah
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Chicago Research Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Department of Psychiatry & Behavioral Neuroscience
      • Naperville, Illinois, United States, 60563
        • AMR-Baber Research, Inc
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Phoenix Medical Research, Inc.
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Pharmasite Research, Inc.
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02131
        • Boston Clinical Trials
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Michigan Clinical Research PC
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • ActivMed Practices and Research, Inc.
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08028
        • Center for Emotional Fitness
    • New York
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials LLC
      • Great Neck, New York, United States, 11021
        • Bio Behavioral Institute
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • New Hope Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas, LP
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Psychiatric Alliance of the Blue Ridge, Inc.
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching capsule once daily (QD)
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
Time Frame: Baseline, Week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase
Time Frame: Up to 12 weeks
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, been life-threatening, or required hospitalization, or, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent other serious outcomes.
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
Time Frame: Up to 96 weeks
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, been life-threatening, or required hospitalization, or, based upon appropriate medical judgment may, have jeopardized the participant and may have required medical or surgical intervention to prevent other serious outcomes.
Up to 96 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase
Time Frame: Up to 12 weeks
Clinically significant laboratory abnormalities were defined as Grade 3 or 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017). Laboratory tests of clinical interest for troriluzole included absolute neutrophil count < 500 per mm^3, alanine aminotransferase or aspartate aminotransferase > 3x upper limit of normal (ULN), and total bilirubin ≥ 2x ULN (Laboratory results were presented in US units).
Up to 12 weeks
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score
Time Frame: Baseline, Week 12
The SDS was assessed in 3 domains: work/school (0-10), social life (0-10), and family life (0-10). The score from each domain was summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). If the participant has not worked or studied for reasons unrelated to OCD, then the total score was considered as missing.
Baseline, Week 12
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score
Time Frame: Baseline, Week 12
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Baseline, Week 12
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score
Time Frame: Baseline, Week 12
The Y-BOCS Obsessions Sub-scale consists of the last 5 items on the Y-BOCS and is measured on a scale of 0 to 20. A higher score on the Y-BOCS corresponds to greater symptom severity.
Baseline, Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8
Time Frame: Baseline, Week 4 and Week 8
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 4 and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Actual)

June 2, 2020

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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