Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

  • End date
    Mar 17, 2023
  • participants needed
  • sponsor
    Biohaven Pharmaceuticals, Inc.
Updated on 18 May 2022
serotonin reuptake inhibitors


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 Obsessive-Compulsive Disorder
Treatment Placebo, troriluzole
Clinical Study IdentifierNCT04641143
SponsorBiohaven Pharmaceuticals, Inc.
Last Modified on18 May 2022


Yes No Not Sure

Inclusion Criteria

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
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
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

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
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
Previous treatment in a study with troriluzole
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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