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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 : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE September 28, 2017
First Posted Date  ICMJE October 2, 2017
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE December 19, 2017
Estimated Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 29, 2017)
Change in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score [ Time Frame: 10 weeks ]
Change from baseline to end of double-blind phase of the study
Change History Complete list of historical versions of study NCT03299166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2018)
  • 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) ]
  • 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). ]
  • 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). ]
  • Change in the Y-BOCS obsessions sub-scale score. [ Time Frame: Change from baseline to the end of the double-blind phase (12 weeks). ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2017)
  • 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 (10 weeks) ]
  • 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 (10 weeks). ]
  • Assessment of the improvement on the clinical global impression of improvement scale (CGI-I). [ Time Frame: As measured by the change from Week 3 to week 10. ]
  • Change in the Y-BOCS obsessions sub-scale score. [ Time Frame: Change from baseline to the end of the double-blind phase (10 weeks). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BHV-4157 in Adult Subjects With Obsessive Compulsive Disorder
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive BHV-4157 in Obsessive Compulsive Disorder
Brief Summary The purpose of this study is to compare the efficacy of BHV-4157 versus placebo in subjects with Obsessive Compulsive Disorder (OCD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Drug: BHV-4157
    BHV-4157, 140mg capsule QD
  • Drug: Placebo
    matching capsule QD
Study Arms  ICMJE
  • Experimental: BHV-4157
    Intervention: Drug: BHV-4157
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2017)
226
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 18, 2020
Estimated Primary Completion Date November 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03299166
Other Study ID Numbers  ICMJE BHV4157-202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biohaven Pharmaceuticals, Inc.
Study Sponsor  ICMJE Biohaven Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biohaven Pharmaceuticals, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP