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Efficacy and Safety Study of Adjunctive Troriluzole in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04641143
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: Troriluzole Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Troriluzole
Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.
 Drug: Troriluzole
Troriluzole - 2 100mg capsules QD for the first two weeks.
Placebo Comparator: Placebo
Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
 Drug: Placebo
Matching placebo - 2 140mg capsules QD from week two through week ten.


Outcome Measures
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Primary Outcome Measures :
  1. The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10 ]
    Improvement is measured by a lower total score


Secondary Outcome Measures :
  1. Frequency of SAEs and AEs leading to discontinuation [ Time Frame: From Screening through study completion, up to 10 weeks ]
    Percent difference between troriluzole vs placebo treatment emergent adverse events.

  2. Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS) [ Time Frame: From baseline through study completion (up to 10 weeks) ]
    Change is measured as "mild" or "moderate" on the SDS

  3. Improvement in global functioning responses assessed on the CGI-I scale. [ Time Frame: From baseline through study completion (up to 10 weeks) ]
    Change is measured as "much improved" or "very much improved" on the CGII scale


Eligibility Criteria
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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, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year
  2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
  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

Exclusion Criteria:

  1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
  2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results
  3. Previous treatment in a study with troriluzole
Contacts and Locations
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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): NCT04641143


Contacts
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Contact: Chief Medical Officer 203-404-0410 clinicaltrials@biohavenpharma.com

Locations
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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
More Information
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04641143    
Other Study ID Numbers: BHV4157-302
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Obsessive-Compulsive Disorder
OCD
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
 Personality Disorders
Mental Disorders
Anxiety Disorders