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BHV-4157 in Adult Subjects With Obsessive Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT03299166
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : December 11, 2018
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

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 : December 31, 2018
Estimated Study Completion Date : December 31, 2019

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). ]


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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 12 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.

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


Contacts
Contact: Robert Berman, MD 203-404-0410 clinicaltrials@biohavenpharma.com

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United States, California
Collaborative Neuroscience Network, LLC Recruiting
Garden Grove, California, United States, 92845
Contact: David Walling, PhD    714-799-7799    davidwalling@cnstrial.com   
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Jennifer Sumner    858-246-1872    jsumner@ucsd.edu   
CalNeuro Research Group Recruiting
Los Angeles, California, United States, 90024
Contact: Alexander Bystritsky    310-208-7144    abystritksy@pacificmedresearch.com   
Synergy Research San Diego Recruiting
National City, California, United States, 91950
Contact: Woody Woodaman    619-327-0155    woody.synergy@gmail.com   
Pacific Research Partners, LLC Recruiting
Oakland, California, United States, 94607
Contact: Shawna Cote    510-444-2877    shawnacote@pacifictrials.com   
NRC Research Institute Recruiting
Orange, California, United States, 92868
Contact: Daniel Chueh, MD    714-289-1100    dchueh@nrcresearch.com   
Artemis Institute for Clinical Research Recruiting
San Diego, California, United States, 92103
Contact: Beth Panella    858-278-3647    bpanella@artemis-research.com   
Artemis Institute for Clinical Research Recruiting
San Marcos, California, United States, 92078
Contact: Brittany Welchers    760-266-4144    bweichers@artemis-research.com   
Stanford University, Department of Psychiatry and Behavioral Sciences Recruiting
Stanford, California, United States, 94305-5717
Contact: Andrea Varias, MSHS    650-723-4095    ocdresearch@stanford.edu   
United States, Connecticut
Institute of Living / Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Allison Brodeur    860-545-7502    allison.brodeur@hhchealth.org   
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Eileen Billingslea    203-974-7768    eileen.billingslea@yale.edu   
United States, Florida
University of Florida Department of Psychiatry Recruiting
Gainesville, Florida, United States, 32606
Contact: Dana Mason    352-273-8540    dmason@ufl.edu   
Galiz Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Luis Pedraza    305-805-0921    luisp@galizresearch.com   
Clinical Neuroscience Solutions, Inc Recruiting
Jacksonville, Florida, United States, 32256
Contact: Susan Angel    904-281-5757    sangel@cnshealthcare.com   
SIH Research, Inc Recruiting
Kissimmee, Florida, United States, 34741
Contact: Kanza Chaudhary    407-483-5389    kanza.chaudhary@sihresearch.org   
Harmony Clinical Research Recruiting
North Miami Beach, Florida, United States, 33162
Contact: Raquel Gamon    305-957-7200    rgamon@hcresearchfl.com   
Medical Research Group of Central Florida Recruiting
Orange City, Florida, United States, 32763
Contact: Megan McMahon    386-775-7627    mmcmahon@mrgcf.com   
Clinical Neuroscience Solutions, Inc Recruiting
Orlando, Florida, United States, 32801
Contact: Patricia Brown    407-425-5100    pbrown@cnshealthcare.com   
United States, Georgia
iResearch Atlanta, LLC Recruiting
Decatur, Georgia, United States, 30030
Contact: Amanda Goza    404-537-1281    amanda.goza@iresearchatlanta.com   
United States, Illinois
University of Chicago Department of Psychiatry & Behavioral Neuroscience Recruiting
Chicago, Illinois, United States, 60637
Contact: Sarah Redden    773-702-9066    sredden@bsd.uchicago.edu   
AMR-Baber Research, Inc Recruiting
Naperville, Illinois, United States, 60563
Contact: Zeshawn Ahmed    312-890-2177    Zeshawn@BaberResearchGroup.com   
United States, Kansas
Phoenix Medical Research, Inc. Recruiting
Prairie Village, Kansas, United States, 66208
Contact: Rebecca Bauer    913-381-7180    bbauer@pmr-kc.com   
Heartland Research Associates, LLC Recruiting
Wichita, Kansas, United States, 67207
Contact: Cindy Thome    316-689-6629    amrbudgets@amrllc.com   
United States, Maryland
Pharmasite Research, Inc. Recruiting
Pikesville, Maryland, United States, 21208
Contact: Jennifer Nelson    410-602-1440    jnelson@pharmasiteresearch.com   
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McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Chris Perriello    617-855-2911    cperriello@mclean.harvard.edu   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachel Porth    617-726-5527    Rporth@mgh.harvard.edu   
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ActivMed Practices and Research, Inc. Recruiting
Portsmouth, New Hampshire, United States, 03801
Contact: Laura Rocha    978-655-7155    lrocha@activemedresearch.com   
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Center for Emotional Fitness Recruiting
Cherry Hill, New Jersey, United States, 08028
Contact: Hayon Choe    856-857-9500 ext 19    kchoe@cfef.com   
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Rachel Middleton    646-774-8138    rachel.middleton@NYSPI.Columbia.edu   
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
Contact: Tracie Doerner    585-241-9670    tdoerner@flclinical.com   
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
Contact: Adam Smith    718-317-5522    smith@rbany.com   
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Midwest Clinical Research Center Recruiting
Dayton, Ohio, United States, 45417
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Summit Research Network (Oregon) Inc. Completed
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Suburban Research Associates Recruiting
Media, Pennsylvania, United States, 19063
Contact: Nadine Varney    610-891-9024 ext 118    nvarney@suburbanresearch.com   
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gina Belli    215-746-3334    gbelli@pennmedicine.upenn.edu   
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Clinical Neuroscience Solutions, Inc. Recruiting
Memphis, Tennessee, United States, 38119
Contact: Charles Grandberry    901-843-1045    cgrandberry@cnshealthcare.com   
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FutureSearch Trials of Dallas, LP Recruiting
Dallas, Texas, United States, 75231
Contact: Erin Ashmore    214-369-2600    erina@fstrials.com   
InSite Clinical Research Recruiting
DeSoto, Texas, United States, 75115
Contact: Brian Green    972-283-6286    bgreen@incr.us   
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Gregory Vogt    713-798-4729    gsvogt@bcm.edu   
United States, Virginia
Psychiatric Alliance of the Blue Ridge, Inc. Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Angel Morris    434-984-6777    morrisangel@pabrcrc.com   
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Contact: Arifulla Kahn    425-453-0404    akhan@nwcrc.net   
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03299166     History of Changes
Other Study ID Numbers: BHV4157-202
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders