Study Stopped
Sponsor Decision
Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
1 other identifier
interventional
772
6 countries
175
Brief Summary
The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2021
Longer than P75 for phase_3
175 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedStudy Start
First participant enrolled
March 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2026
CompletedFebruary 25, 2026
February 1, 2026
4.9 years
January 11, 2021
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment
Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.
Change from Baseline to week 240
Study Arms (1)
Troriluzole (BHV-4157)
EXPERIMENTAL200 mg daily first 2 weeks, 280 daily following first 2 weeks
Interventions
200 mg daily first 2 weeks, 280 daily following first 2 weeks
Eligibility Criteria
You may qualify if:
- Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.
- Determined by the investigator to be medically stable at the week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
- It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study
You may not qualify if:
- Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.
- Acute suicidality or suicide attempt or self injurious behavior in the last 12 months.
- Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (175)
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, 85226, United States
Alea Research
Phoenix, Arizona, 85012, United States
NoeisisPharma, LLC
Phoenix, Arizona, 85016, United States
Atria Clinical Research
Little Rock, Arkansas, 72209, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
CITrials (Clinical Innovations)
Bellflower, California, 90706, United States
Southern California Research, LLC
Beverly Hills, California, 90210, United States
Axiom Research, LLC
Colton, California, 92324, United States
Global Clinical Trials
Costa Mesa, California, 92627, United States
ProScience Research Group
Culver City, California, 90230, United States
WR-PRI, LLC (Encino)
Encino, California, 91316, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Sun Valley Research Center, Inc.
Imperial, California, 92251, United States
Om Research LLC
Lancaster, California, 93534, United States
Synergy Research San Diego
Lemon Grove, California, 91945, United States
Alliance for Research
Long Beach, California, 90807, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
CalNeuro Research Group
Los Angeles, California, 90024, United States
Clarity Clinical Research
Los Angeles, California, 90064, United States
Pharmacology Research Institute (WR-PRI, LLC)
Newport Beach, California, 92660, United States
Pacific Research Partners
Oakland, California, 94607, United States
North County Clinical Research
Oceanside, California, 92054, 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
CI Trials
Riverside, California, 92506, United States
ACRC Studies
San Diego, California, 92119, United States
Lumos Clinical Research Center, LLC
San Jose, California, 95124, United States
National Research Institute
Santa Ana, California, 92704, 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
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Mountain View Clinical Research
Denver, Colorado, 80209, United States
Institute of Living / Hartford Hospital
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06519, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Topaz Clinical Research
Apopka, Florida, 32703, United States
Boca Raton Medical Institute
Boca Raton, Florida, 33431, United States
Advanced Clinical Research Network
Coral Gables, Florida, 33134, United States
CNS Research of Coral Springs
Coral Springs, Florida, 33067, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
University of Florida Department of Psychiatry
Gainesville, Florida, 32606, United States
Qway Research, LLC
Hialeah, Florida, 33010, United States
Research in Miami Inc
Hialeah, Florida, 33013, United States
Health Care Family Rehab & Research
Hialeah, Florida, 33015, United States
Galiz Research
Hialeah, Florida, 33016, United States
Clinical Neuroscience Solutions, Inc
Jacksonville, Florida, 90024, United States
Accel Research Sites (formerly Meridien Research)
Lakeland, Florida, 33803, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319, United States
Pharmaceutical Research Center, Inc.
Lutz, Florida, 33548, United States
ClinCloud, LLC
Maitland, Florida, 32751, United States
Meridien Research
Maitland, Florida, 32751, United States
Central Miami Medical Institute
Miami, Florida, 33125, United States
Clintex Research
Miami, Florida, 33135, United States
Sanchez Clinical Research Inc
Miami, Florida, 33157, United States
Med-Care Research
Miami, Florida, 33165, United States
FIRC
Miami, Florida, 33173, United States
Florida Research Center, Inc.
Miami, Florida, 33174, United States
Ezy Medical Research, Co.
Miami, Florida, 33175, United States
Miami Dade Medical Research Institute
Miami, Florida, 33176, United States
Pro-Care Research Center
Miami Gardens, Florida, 33014, United States
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida, 33166, United States
Advanced Research for Health Improvement
Naples, Florida, 34102, United States
Bayside Clinical Research, LLC
New Port Richey, Florida, 34655, United States
Bravo Health Care Center
North Bay Village, Florida, 33141, United States
Behavioral Clinical Research
North Miami, Florida, 33161, United States
Harmony Clinical Research
North Miami Beach, Florida, 33162, 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
IMIC Inc
Palmetto Bay, Florida, 33157, United States
MedBio Trials
Pembroke Pines, Florida, 33026, United States
DMI Research
Pinellas Park, Florida, 33782, United States
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Olympian Clinical Research
Tampa, Florida, 33614, United States
Conquest Research LLC
Winter Park, Florida, 32789, United States
NeuroTrials Research Inc
Atlanta, Georgia, 30328, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
iResearch Savannah
Savannah, Georgia, 31405, United States
Renew Health Clinical Research, LLC
Snellville, Georgia, 30078, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
University of Chicago Department of Psychiatry & Behavioral Neuroscience
Chicago, Illinois, 91786, United States
Revive Research Institute
Elgin, Illinois, 60123, United States
Capstone Clinical Research
Libertyville, Illinois, 60048, United States
AMR-Baber Research, Inc
Naperville, Illinois, 60563, United States
Collective Medical Research
Prairie Village, Kansas, 66208, United States
Northern Light Acadia Hospital
Bangor, Maine, 04401, United States
CBH Health
Gaithersburg, Maryland, 20877, United States
Pharmasite Research, Inc.
Pikesville, Maryland, 21208, United States
Continental Clinical Solutions, LLC
Towson, Maryland, 21204, 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
Adams Clinical
Watertown, Massachusetts, 02472, 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
PsychCare Consultants Research
St Louis, Missouri, 63128, United States
Boeson Research
Missoula, Montana, 59804, United States
Altea Research
Las Vegas, Nevada, 89102, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Integrative Clinical Trials, LLC
Brooklyn, New York, 11229, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, 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
Hapworth Research
New York, New York, 10019, United States
New York State Psychiatric Institute
New York, New York, 10032, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303, United States
Clinical Inquest Center, Ltd
Beavercreek, Ohio, 45431, United States
NeuroScience Research Center, LLC.
Canton, Ohio, 44718, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
IPS Research
Oklahoma City, Oklahoma, 73106, United States
Central States Research, LLC
Tulsa, Oklahoma, 74136, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
BioBehavioral Research of Austin
Austin, Texas, 78759, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
DiscoveResearch, Inc. (DRI)
Bryan, Texas, 77802, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231, United States
Relaro Medical Trials
Dallas, Texas, 75243, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
North Texas Clinical Trials
Fort Worth, Texas, 76104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Texas Center for Drug Development, Inc.
Houston, Texas, 77081, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
Mt.Olympus Medical Research LLC
Missouri City, Texas, 77459, United States
AIM Trials
Plano, Texas, 75093, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Grayline Research Center
Wichita Falls, Texas, 76309, United States
Woodstock Research Center
Woodstock, Vermont, 05091, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, N7L 1C1, Canada
McMaster University, Hamilton Health Sciences
Hamilton, Ontario, L8S 1B7, Canada
Queen's University
Kingston, Ontario, K7L 5G2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
START Clinic for Mood and Anxiety Disorders
Toronto, Ontario, M4W 2N4, Canada
University of Toronto / Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H4, Canada
Institute of Neuroscience, University of Firenze
Florence, 50121, Italy
ASST FBF SACCO - Ospedale Universitario Luigi Sacco
Milan, 20157, Italy
University School of Medicine of Napoli Federico II
Naples, 80131, Italy
University of Pisa
Pisa, 56126, Italy
University of Turin - university hospital san luigi gonzaga
Turin, 10043, Italy
Amsterdam UMC, locatie AMC
Amsterdam, 1100, Netherlands
Leiden University Medical Center (LUMC)
Leiden, 2333, Netherlands
Hospital Universitario de Bellvitge
Barcelona, 08907, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Centro de Salud Mental La Corredoria
Oviedo, 33011, Spain
Centro de Salud San Juan
Salamanca, 37005, Spain
Hospital Álvaro Cunqueiro
Vigo, 36312, Spain
MAC Clinical Research-Lancashire
Blackpool, FY2 0JH, United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 0AE, United Kingdom
MAC Clinical Research -- Merseyside
Liverpool, L34 1BH, United Kingdom
South West London and St George's Mental Health NHS Trust Springfield University Hospital
London, SW17 7DJ, United Kingdom
MAC Clinical Research-Greater Manchester
Manchester, M13 9NQ, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M25 3BL, United Kingdom
Bioluminux Ltd
Milton Keynes, MK15 0DU, United Kingdom
MAC Clinical Research-- South Yorkshire
Tankersley, S75 3DL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 14, 2021
Study Start
March 30, 2021
Primary Completion
February 13, 2026
Study Completion
February 13, 2026
Last Updated
February 25, 2026
Record last verified: 2026-02