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Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT04693351
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The study's purpose its 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 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 : January 29, 2021
Estimated Primary Completion Date : March 17, 2023
Estimated Study Completion Date : March 17, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.

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
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.




Primary Outcome Measures :
  1. The total score on the Yale-Brown Obsessive Compulsive Disorder (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 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 function disability as assessed by the change in the 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 as 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 CGI-I scale.



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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

Key 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 subjects illness must be ≥ 1year
  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 too current standard of car base on the YBOCS score.
  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 trail as designed.

Key Exclusion Criteria:

  1. Subjects with a history of more than two (2) previous fails or inadequate 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 MGH-TRQ-OCD.
  2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism 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

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): NCT04693351


Contacts
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Contact: Elyse Stock, MD 203-404-0410 clinicaltrials@biohavenpharma.com

Locations
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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04693351    
Other Study ID Numbers: BHV4157-303
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

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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