BHV-4157 in Adult Subjects With Obsessive Compulsive Disorder

A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive BHV-4157 in Obsessive Compulsive Disorder

The purpose of this study is to compare the efficacy of BHV-4157 versus placebo in subjects with Obsessive Compulsive Disorder (OCD).

Study Overview

• Status: Active, not recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Drug: BHV-4157; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • 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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders.

2. Subjects must be currently experiencing non-response or inadequate response to their current Standard of Care (SOC) medication defined as:

   1. Subjects Y-BOCS total score must be ≥ 19 at Screening and Baseline, reflecting moderate or severe OCD symptoms.
   2. Subjects must currently be on a selective serotonin reuptake inhibitor (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. Subjects 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. Subjects must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
6. Subjects 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. Women of childbearing potential 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 two 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).

Exclusion Criteria:

1. Subjects should be excluded with a history of more than two (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 MGH-TRQ-OCD as:

   1. Treatment failure / non-response: As per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the patient 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 USPI labeling.
2. Current or prior history, per DSM-V 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;
3. Any eating disorder within the last 12 months;
4. Acute suicidality or suicide attempt or self-injurious behavior in the last 6 months;
5. History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).
6. Transcranial Magnetic Stimulation (TMS) is prohibited within three months prior to screening and during the study.
7. Patients 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.
8. Creatinine ≥ 2 mg/dL.
9. Course of treatment for subjects with localized cancers (without metastatic spread) is 5 years prior to screening.
10. 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 ECG findings that, in the investigator's opinion, would preclude participation in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching capsule once daily (QD)
Experimental: BHV-4157	Drug: BHV-4157; BHV-4157, 140mg capsule once daily (QD); Other Names: troriluzole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score	Change from baseline to end of double-blind phase of the study	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability assessed using the frequency of subjects with serious adverse events, adverse events leading to discontinuation, and adverse events judged to be related to study medication.	during the double-blind phase (12 weeks)
Improvement in functional disability assessed using the Sheehan Disability Scale (SDS) total score.	Change from baseline to the end of the double-blind phase (12 weeks).
Assessment of the improvement on the clinical global impression of severity scale (CGI-S).	As measured by the change at the end of the double-blind phase of the study (Week 12).
Change in the Y-BOCS obsessions sub-scale score.	Change from baseline to the end of the double-blind phase (12 weeks).

Collaborators and Investigators

• Sponsor: Biohaven Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Actual): June 2, 2020
• Study Completion (Anticipated): March 14, 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): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: BHV4157-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No