Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder
NCT ID: NCT04641143
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
456 participants
INTERVENTIONAL
2020-12-22
2025-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Troriluzole
Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.
Troriluzole
Troriluzole - 2 100mg capsules QD for the first two weeks.
Placebo
Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
Placebo
Matching placebo - 2 140mg capsules QD from week two through week ten.
Interventions
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Troriluzole
Troriluzole - 2 100mg capsules QD for the first two weeks.
Placebo
Matching placebo - 2 140mg capsules QD from week two through week ten.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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Biohaven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Metropolitan Neuro Behavioral Institute
Chandler, Arizona, United States
IMA Clinical Research
Phoenix, Arizona, United States
NoeisisPharma, LLC
Phoenix, Arizona, United States
CITrials (Clinical Innovations)
Bellflower, California, United States
Axiom Research, LLC
Colton, California, United States
WR-PRI, LLC (Encino)
Encino, California, United States
Behavioral Research Specialists, LLC
Glendale, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Clarity Clinical Research
Los Angeles, California, United States
Excell Research, Inc
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
Anderson Clinical Research
Redlands, California, United States
Lumos Clinical Research Center, LLC
San Jose, California, United States
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, United States
Stanford University
Stanford, California, United States
Collaborative Neuroscience Research
Torrance, California, United States
Yale University / Connecticut Mental Health Center
New Haven, Connecticut, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Boca Raton Medical Institute
Boca Raton, Florida, United States
Advanced Clinical Research Network
Coral Gables, Florida, United States
Research in Miami Inc
Hialeah, Florida, United States
Accel Research Sites
Lakeland, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Health Care Family Rehab & Research
Miami, Florida, United States
Central Miami Medical Institute
Miami, Florida, United States
FIRC
Miami, Florida, United States
Florida Research Center, Inc.
Miami, Florida, United States
South Florida Research Phase I-IV , Inc.
Miami Springs, Florida, United States
Behavioral Clinical Research
North Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
APG Research, LLC
Orlando, Florida, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
Omega Research Consultants
Orlando, Florida, United States
MedBio Trials
Pembroke Pines, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Neurobehaviorial Institute
Weston, Florida, United States
Conquest Research LLC
Winter Park, Florida, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
iResearch Savannah
Savannah, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Uptown Research Institute
Chicago, Illinois, United States
Revive Research Institute
Elgin, Illinois, United States
AMR-Baber Research, Inc
Naperville, Illinois, United States
Collective Medical Research
Overland Park, Kansas, United States
CBH Health
Gaithersburg, Maryland, United States
Pharmasite Research, Inc.
Pikesville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Clinical Trials
Boston, Massachusetts, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
Sisu at RMG
Springfield, Massachusetts, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Altea Research
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, United States
Neurobehavioral Research, Inc
Cedarhurst, New York, United States
Bio Behavioral Institute
Great Neck, New York, United States
Bioscience Research, LLC
Mount Kisco, New York, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Clinical Inquest Center, Ltd
Beavercreek, Ohio, United States
Central States Research, LLC
Tulsa, Oklahoma, United States
Suburban Research Associates
Media, Pennsylvania, United States
Comprehensive Psychiatric Care Providers
Providence, Rhode Island, United States
BioBehavioral Research of Austin
Austin, Texas, United States
Relaro Medical Trials
Dallas, Texas, United States
North Texas Clinical Trials
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Mt.Olympus Medical Research LLC
Missouri City, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Other Identifiers
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BHV4157-302
Identifier Type: -
Identifier Source: org_study_id
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