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Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

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Conditions

Obsessive-Compulsive DisorderOCD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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

Quick Facts

Study Start:2020-12-22
Study Completion:2025-10-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04641143

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 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. 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. 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. 3. Previous treatment in a study with troriluzole

Contacts and Locations

Study Locations (Sites)

Metropolitan Neuro Behavioral Institute
Chandler, Arizona, 85284
United States
IMA Clinical Research
Phoenix, Arizona, 85012
United States
NoeisisPharma, LLC
Phoenix, Arizona, 85016
United States
CITrials (Clinical Innovations)
Bellflower, California, 90706
United States
Axiom Research, LLC
Colton, California, 92324
United States
WR-PRI, LLC (Encino)
Encino, California, 91316
United States
Behavioral Research Specialists, LLC
Glendale, California, 91206
United States
Pharmacology Research Institute
Los Alamitos, California, 90720
United States
Clarity Clinical Research
Los Angeles, California, 90064
United States
Excell Research, Inc
Oceanside, California, 92056
United States
NRC Research Institute
Orange, California, 92688
United States
Anderson Clinical Research
Redlands, California, 92374
United States
Lumos Clinical Research Center, LLC
San Jose, California, 95124
United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403
United States
Stanford University
Stanford, California, 94305
United States
Collaborative Neuroscience Research
Torrance, California, 90502
United States
Yale University / Connecticut Mental Health Center
New Haven, Connecticut, 06519
United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
United States
Boca Raton Medical Institute
Boca Raton, Florida, 33431
United States
Advanced Clinical Research Network
Coral Gables, Florida, 33134
United States
Research in Miami Inc
Hialeah, Florida, 33013
United States
Accel Research Sites
Lakeland, Florida, 33803
United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
United States
Health Care Family Rehab & Research
Miami, Florida, 33015
United States
Central Miami Medical Institute
Miami, Florida, 33125
United States
FIRC
Miami, Florida, 33173
United States
Florida Research Center, Inc.
Miami, Florida, 33174
United States
South Florida Research Phase I-IV , Inc.
Miami Springs, Florida, 33166
United States
Behavioral Clinical Research
North Miami, Florida, 33161
United States
Medical Research Group of Central Florida
Orange City, Florida, 32763
United States
APG Research, LLC
Orlando, Florida, 32803
United States
Combined Research Orlando Phase I-IV
Orlando, Florida, 32807
United States
Omega Research Consultants
Orlando, Florida, 32808
United States
MedBio Trials
Pembroke Pines, Florida, 33026
United States
Stedman Clinical Trials
Tampa, Florida, 33613
United States
Neurobehaviorial Institute
Weston, Florida, 33326
United States
Conquest Research LLC
Winter Park, Florida, 32789
United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030
United States
iResearch Savannah
Savannah, Georgia, 31405
United States
Northwest Clinical Trials
Boise, Idaho, 83704
United States
Uptown Research Institute
Chicago, Illinois, 60640
United States
Revive Research Institute
Elgin, Illinois, 60123
United States
AMR-Baber Research, Inc
Naperville, Illinois, 60563
United States
Collective Medical Research
Overland Park, Kansas, 66210
United States
CBH Health
Gaithersburg, Maryland, 20877
United States
Pharmasite Research, Inc.
Pikesville, Maryland, 21208
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Clinical Trials
Boston, Massachusetts, 02131
United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844
United States
Sisu at RMG
Springfield, Massachusetts, 01103
United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, 48105
United States
Precise Research Centers
Flowood, Mississippi, 39232
United States
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368
United States
Altea Research
Las Vegas, Nevada, 89102
United States
Hassman Research Institute
Berlin, New Jersey, 08009
United States
Bio Behavioral Health
Toms River, New Jersey, 08755
United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229
United States
Neurobehavioral Research, Inc
Cedarhurst, New York, 11516
United States
Bio Behavioral Institute
Great Neck, New York, 11021
United States
Bioscience Research, LLC
Mount Kisco, New York, 10549
United States
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036
United States
Richmond Behavioral Associates
Staten Island, New York, 10312
United States
Clinical Inquest Center, Ltd
Beavercreek, Ohio, 45431
United States
Central States Research, LLC
Tulsa, Oklahoma, 74136
United States
Suburban Research Associates
Media, Pennsylvania, 19063
United States
Comprehensive Psychiatric Care Providers
Providence, Rhode Island, 02906
United States
BioBehavioral Research of Austin
Austin, Texas, 78759
United States
Relaro Medical Trials
Dallas, Texas, 75243
United States
North Texas Clinical Trials
Fort Worth, Texas, 76104
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
United States
Mt.Olympus Medical Research LLC
Missouri City, Texas, 77459
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: Biohaven Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-22
Study Completion Date2025-10-27

Study Record Updates

Study Start Date2020-12-22
Study Completion Date2025-10-27

Terms related to this study

Keywords Provided by Researchers

  • Obsessive-Compulsive Disorder
  • OCD

Additional Relevant MeSH Terms

  • Obsessive-Compulsive Disorder