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Trial record 8 of 84 for:    Recruiting Studies | obsessive compulsive disorder

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 : April 8, 2019
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 : November 18, 2019
Estimated Study Completion Date : November 18, 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). ]


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

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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

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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: April 8, 2019
Last Verified: April 2019

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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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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders