Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder
NCT ID: NCT04693351
Last Updated: 2025-08-19
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
589 participants
INTERVENTIONAL
2021-01-29
2025-04-29
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
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
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
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
Interventions
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Troriluzole
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
Placebo
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 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 too current standard of car base on the YBOCS score.
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 trail as designed.
Exclusion Criteria
2. 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.
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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Alea Research
Phoenix, Arizona, United States
ProScience Research Group
Culver City, California, United States
Kaizen Brain Center
La Jolla, California, United States
Om Research LLC
Lancaster, California, United States
CalNeuro Research Group
Los Angeles, California, United States
Lumos Clinical Research Center, LLC
San Jose, California, United States
Velocity Clinical Research
Santa Ana, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Mountain View Clinical Research
Denver, Colorado, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Topaz Clinical Research
Apopka, Florida, United States
CNS Research of Coral Springs
Coral Springs, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
University of Florida Department of Psychiatry
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Med-Care Research
Miami, Florida, United States
Ezy Medical Research, Co.
Miami, Florida, United States
Advanced Research for Health Improvement
Naples, Florida, United States
Harmony Clinical Research
North Miami Beach, Florida, United States
dTMS Center LLC
Palm Beach, Florida, United States
DMI Research
Pinellas Park, Florida, United States
CenExel iResearch
Decatur, Georgia, United States
Renew Health Clinical Research, LLC
Snellville, Georgia, United States
University of Chicago Department of Psychiatry & Behavioral Neuroscience
Chicago, Illinois, United States
AMR-Baber Research, Inc.
Naperville, Illinois, United States
Collective Medical Research
Overland Park, Kansas, United States
Continental Clinical Solutions, LLC
Towson, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Boeson Research
Missoula, Montana, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, United States
Richard H. Weisler, MD PA & Associates
Raleigh, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
American Clinical Research Institute (ACRI)
Dayton, Ohio, United States
American Research Institute (ACRI)
Kettering, Ohio, United States
North Star Medical Research, LLC
Middleburg Heights, Ohio, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
Donald J. Garcia Jr., MD PA
Austin, Texas, United States
Inquest Clinical Research
Baytown, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Clinical Trial Network
Houston, Texas, United States
AIM Trials
Plano, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Woodstock Research Center
Woodstock, Vermont, United States
University of Calgary
Calgary, Alberta, Canada
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada
McMaster University, Hamilton Health Sciences
Hamilton, Ontario, Canada
Queen's University
Kingston, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
START Clinic for Mood and Anxiety Disorders
Toronto, Ontario, Canada
University of Toronto / Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
Beijing HuiLongGuan Hospital
Beijing, Changping District, China
Peking University Sixth Hospital
Beijing, Haidian District, China
Hangzhou Seventh People's Hospital
Hangzhou, Hangzhou City, China
Tianjin Anding Hospital
Tianjin, Hexi District, China
The Second Xiangya Hospital of Central South University
Xiangya, Hunan, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Shanghai Mental Health Center
Shanghai, Minhang District, China
Wuhan Mental Health Center
Wuhan, Qiaokou District, China
The First Affiliated Hospital of Jinan University
Guangzhou, Tianhe District, China
Mental Health Center, West China Hospital, Sichuan University
Chengdu, Wuhou District, China
First Hospital of Hebei Medical University
Shijiazhuang, Yuhua District, China
ASST FBF SACCO - Ospedale Universitario Luigi Sacco
Milan, , Italy
University School of Medicine of Napoli Federico II
Naples, , Italy
University of Pisa
Pisa, , Italy
University of Turin - university hospital san luigi gonzaga
Turin, , Italy
Amsterdam UMC, locatie AMC
Amsterdam, , Netherlands
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Hospital Universitario de Bellvitge
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Centro de Salud Mental La Corredoria
Oviedo, , Spain
Centro de Salud San Juan
Salamanca, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
MAC Clinical Research
Stockton-on-Tees, County Durham, United Kingdom
Stemax Consult - Healthcare Services Ltd
Stony Stratford, Northamptonshire, United Kingdom
MAC Clinical Research - South Staffordshire
Cannock, South Staffordshire, United Kingdom
MAC Clinical Research-Lancashire
Blackpool, , United Kingdom
MAC Clinical Research
Leeds, , United Kingdom
MAC Clinical Research -- Merseyside
Liverpool, , United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, , United Kingdom
Bioluminux Ltd
Milton Keynes, , United Kingdom
Kingshill Research Centre
Swindon, , United Kingdom
MAC Clinical Research-- South Yorkshire
Tankersley, , United Kingdom
Countries
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Other Identifiers
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BHV4157-303
Identifier Type: -
Identifier Source: org_study_id
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