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BHV-4157 in Adult Subjects With Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299166
Recruitment Status : Active, not recruiting
First Posted : October 2, 2017
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: BHV-4157 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive BHV-4157 in Obsessive Compulsive Disorder
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BHV-4157 Drug: BHV-4157
BHV-4157, 140mg capsule QD

Placebo Comparator: Placebo Drug: Placebo
matching capsule QD




Primary Outcome Measures :
  1. Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score [ Time Frame: 12 weeks ]
    Change from baseline to end of double-blind phase of the study


Secondary Outcome Measures :
  1. 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. [ Time Frame: during the double-blind phase (12 weeks) ]
  2. Improvement in functional disability assessed using the Sheehan Disability Scale (SDS) total score. [ Time Frame: Change from baseline to the end of the double-blind phase (12 weeks). ]
  3. Assessment of the improvement on the clinical global impression of severity scale (CGI-S). [ Time Frame: As measured by the change at the end of the double-blind phase of the study (Week 12). ]
  4. Change in the Y-BOCS obsessions sub-scale score. [ Time Frame: Change from baseline to the end of the double-blind phase (12 weeks). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299166


Locations
Hide Hide 57 study locations
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United States, Arizona
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, United States, 85226
United States, Arkansas
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
University of California San Diego
La Jolla, California, United States, 92037
Synergy Research San Diego
Lemon Grove, California, United States, 91945
CalNeuro Research Group
Los Angeles, California, United States, 90024
Pacific Research Partners, LLC
Oakland, California, United States, 94607
NRC Research Institute
Orange, California, United States, 92868
Desert Valley Research
Rancho Mirage, California, United States, 92270
Artemis Institute for Clinical Research
San Diego, California, United States, 92103
Artemis Institute for Clinical Research
San Marcos, California, United States, 92078
Stanford University, Department of Psychiatry and Behavioral Sciences
Stanford, California, United States, 94305-5717
Pacific Clinical Research Medical Group
Upland, California, United States, 91786
United States, Colorado
Mountain View Clinical Research, Inc.
Denver, Colorado, United States, 80209
United States, Connecticut
Institute of Living / Hartford Hospital
Hartford, Connecticut, United States, 06106
Yale University
New Haven, Connecticut, United States, 06519
Comprehensive Psychiatric Care
Norwich, Connecticut, United States, 06360
United States, Florida
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States, 33912
University of Florida Department of Psychiatry
Gainesville, Florida, United States, 32606
Galiz Research
Hialeah, Florida, United States, 33016
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, United States, 32256
SIH Research, Inc
Kissimmee, Florida, United States, 34741
Harmony Clinical Research
North Miami Beach, Florida, United States, 33162
Medical Research Group of Central Florida
Orange City, Florida, United States, 32763
Clinical Neuroscience Solutions, Inc
Orlando, Florida, United States, 32801
United States, Georgia
iResearch Atlanta, LLC
Decatur, Georgia, United States, 30030
iResearch Savannah
Savannah, Georgia, United States, 31405
United States, Illinois
Chicago Research Center
Chicago, Illinois, United States, 60634
University of Chicago Department of Psychiatry & Behavioral Neuroscience
Chicago, Illinois, United States, 60637
AMR-Baber Research, Inc
Naperville, Illinois, United States, 60563
United States, Kansas
Phoenix Medical Research, Inc.
Prairie Village, Kansas, United States, 66208
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Maryland
Pharmasite Research, Inc.
Pikesville, Maryland, United States, 21208
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
United States, Michigan
Michigan Clinical Research PC
Ann Arbor, Michigan, United States, 48105
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, New Hampshire
ActivMed Practices and Research, Inc.
Portsmouth, New Hampshire, United States, 03801
United States, New Jersey
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08028
United States, New York
Integrative Clinical Trials LLC
Brooklyn, New York, United States, 11229
Bio Behavioral Institute
Great Neck, New York, United States, 11021
New York State Psychiatric Institute
New York, New York, United States, 10032
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
New Hope Clinical Research
Charlotte, North Carolina, United States, 28211
United States, Ohio
New Horizons Clinical Research
Cincinnati, Ohio, United States, 45242
Midwest Clinical Research Center
Dayton, Ohio, United States, 45417
United States, Oregon
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States, 75231
InSite Clinical Research
DeSoto, Texas, United States, 75115
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Psychiatric Alliance of the Blue Ridge, Inc.
Charlottesville, Virginia, United States, 22903
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03299166    
Other Study ID Numbers: BHV4157-202
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders