Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

  • STATUS
    Recruiting
  • End date
    Mar 17, 2023
  • participants needed
    600
  • sponsor
    Biohaven Pharmaceuticals, Inc.
Updated on 2 September 2021
Investigator
Robert Berman, MD
Primary Contact
AMR-Baber Research, Inc. (7.6 mi away) Contact
+89 other location
fluvoxamine
serotonin reuptake inhibitors
clomipramine

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)

Details
Condition Obsessive-Compulsive Disorder, ANXIETY NEUROSIS, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders, obsessive compulsive disorder
Treatment Placebo, troriluzole
Clinical Study IdentifierNCT04693351
SponsorBiohaven Pharmaceuticals, Inc.
Last Modified on2 September 2021

Eligibility

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 subjects illness must be 1year
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
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

Exclusion Criteria

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
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
Previous treatment in a study with troriluzole
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