Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Description

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)

Conditions

Obsessive-Compulsive Disorder

Study Overview

Study Details

Study overview

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)

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Condition
Obsessive-Compulsive Disorder
Intervention / Treatment

-

Contacts and Locations

Chandler

Metropolitan Neuro Behavioral Institute, Chandler, Arizona, United States, 85284

Phoenix

NoeisisPharma, LLC, Phoenix, Arizona, United States, 85016

Little Rock

Atria Clinical Research, Little Rock, Arkansas, United States, 72209

Anaheim

Advanced Research Center, Inc., Anaheim, California, United States, 92805

Bellflower

CITrials (Clinical Innovations), Bellflower, California, United States, 90706

Colton

Axiom Research, LLC, Colton, California, United States, 92324

Costa Mesa

Global Clinical Trials, Costa Mesa, California, United States, 92627

Encino

WR-PRI, LLC (Encino), Encino, California, United States, 91316

Glendale

Behavioral Research Specialists, LLC, Glendale, California, United States, 91206

Lemon Grove

Synergy Research San Diego, Lemon Grove, California, United States, 91945

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Biohaven Pharmaceuticals, Inc.,

Study Record Dates

2024-12