Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
- Registration Number
- NCT04708834
- Lead Sponsor
- Biohaven Pharmaceuticals, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1200
- 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
Key
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Troriluzole (BHV-4157) Troriluzole (BHV-4157) 200 mg daily first 2 weeks, 280 daily for following 46 weeks
- Primary Outcome Measures
Name Time Method 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 Change from Baseline to week 48 Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (175)
CalNeuro Research Group
🇺🇸Los Angeles, California, United States
Clarity Clinical Research
🇺🇸Los Angeles, California, United States
University of Chicago Department of Psychiatry & Behavioral Neuroscience
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
START Clinic for Mood and Anxiety Disorders
🇨🇦Toronto, Ontario, Canada
Altea Research
🇺🇸Las Vegas, Nevada, United States
Clintex Research
🇺🇸Miami, Florida, United States
Sanchez Clinical Research Inc
🇺🇸Miami, Florida, United States
Med-Care Research
🇺🇸Miami, Florida, United States
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Ezy Medical Research, Co.
🇺🇸Miami, Florida, United States
Miami Dade Medical Research Institute
🇺🇸Miami, Florida, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
CI Trials
🇺🇸Riverside, California, United States
California Neuroscience Research Medical Group, Inc
🇺🇸Sherman Oaks, California, United States
National Research Institute
🇺🇸Santa Ana, California, United States
Advanced Clinical Research Network
🇺🇸Coral Gables, Florida, United States
Institute of Living / Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Stanford University
🇺🇸Stanford, California, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Topaz Clinical Research
🇺🇸Apopka, Florida, United States
CNS Research of Coral Springs
🇺🇸Coral Springs, Florida, United States
ACRC Studies
🇺🇸San Diego, California, United States
Boca Raton Medical Institute
🇺🇸Boca Raton, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Jacksonville, Florida, United States
NRC Research Institute
🇺🇸Orange, California, United States
Lumos Clinical Research Center, LLC
🇺🇸San Jose, California, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Accel Research Sites (formerly Meridien Research)
🇺🇸Lakeland, Florida, United States
Research in Miami Inc
🇺🇸Hialeah, Florida, United States
Collaborative Neuroscience Research
🇺🇸Torrance, California, United States
Galiz Research
🇺🇸Hialeah, Florida, United States
Meridien Research
🇺🇸Maitland, Florida, United States
Pro-Care Research Center
🇺🇸Miami Gardens, Florida, United States
FIRC
🇺🇸Miami, Florida, United States
Mt.Olympus Medical Research LLC
🇺🇸Missouri City, Texas, United States
University School of Medicine of Napoli Federico II
🇮🇹Naples, Italy
University of Pisa
🇮🇹Pisa, Italy
Relaro Medical Trials
🇺🇸Dallas, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Institute of Neuroscience, University of Firenze
🇮🇹Florence, Italy
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
University of Toronto / Centre for Addiction and Mental Health (CAMH)
🇨🇦Toronto, Ontario, Canada
McMaster University, Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
AIM Trials
🇺🇸Plano, Texas, United States
North Texas Clinical Trials
🇺🇸Fort Worth, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Boeson Research
🇺🇸Missoula, Montana, United States
Alea Research
🇺🇸Phoenix, Arizona, United States
NoeisisPharma, LLC
🇺🇸Phoenix, Arizona, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Central Miami Medical Institute
🇺🇸Miami, Florida, United States
Southern California Research, LLC
🇺🇸Beverly Hills, California, United States
Alliance for Research
🇺🇸Long Beach, California, United States
Metropolitan Neuro Behavioral Institute
🇺🇸Chandler, Arizona, United States
Atria Clinical Research
🇺🇸Little Rock, Arkansas, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
WR-PRI, LLC (Encino)
🇺🇸Encino, California, United States
Synergy Research San Diego
🇺🇸Lemon Grove, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Pharmacology Research Institute (WR-PRI, LLC)
🇺🇸Newport Beach, California, United States
Pacific Research Partners
🇺🇸Oakland, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
North County Clinical Research
🇺🇸Oceanside, California, United States
Sun Valley Research Center, Inc.
🇺🇸Imperial, California, United States
Health Care Family Rehab & Research
🇺🇸Hialeah, Florida, United States
Qway Research, LLC
🇺🇸Hialeah, Florida, United States
CITrials (Clinical Innovations)
🇺🇸Bellflower, California, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Pharmaceutical Research Center, Inc.
🇺🇸Lutz, Florida, United States
Axiom Research, LLC
🇺🇸Colton, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
Global Clinical Trials
🇺🇸Costa Mesa, California, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
South Florida Research Phase I-IV, Inc.
🇺🇸Miami Springs, Florida, United States
Bayside Clinical Research, LLC
🇺🇸New Port Richey, Florida, United States
Advanced Research for Health Improvement
🇺🇸Naples, Florida, United States
Bravo Health Care Center
🇺🇸North Bay Village, Florida, United States
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Harmony Clinical Research
🇺🇸North Miami Beach, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Behavioral Clinical Research
🇺🇸North Miami, Florida, United States
MedBio Trials
🇺🇸Pembroke Pines, Florida, United States
IMIC Inc
🇺🇸Palmetto Bay, Florida, United States
Lenus Research & Medical Group, LLC
🇺🇸Sweetwater, Florida, United States
DMI Research
🇺🇸Pinellas Park, Florida, United States
Conquest Research LLC
🇺🇸Winter Park, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
iResearch Savannah
🇺🇸Savannah, Georgia, United States
Renew Health Clinical Research, LLC
🇺🇸Snellville, Georgia, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Revive Research Institute
🇺🇸Elgin, Illinois, United States
Collective Medical Research
🇺🇸Prairie Village, Kansas, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
AMR-Baber Research, Inc
🇺🇸Naperville, Illinois, United States
Northern Light Acadia Hospital
🇺🇸Bangor, Maine, United States
Pharmasite Research, Inc.
🇺🇸Pikesville, Maryland, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
Continental Clinical Solutions, LLC
🇺🇸Towson, Maryland, United States
Sisu at RMG
🇺🇸Springfield, Massachusetts, United States
ActivMed Practices and Research
🇺🇸Methuen, Massachusetts, United States
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Psychiatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Hapworth Research
🇺🇸New York, New York, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Bio Behavioral Institute
🇺🇸Great Neck, New York, United States
Integrative Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Neurobehavioral Research, Inc
🇺🇸Cedarhurst, New York, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Bioscience Research, LLC
🇺🇸Mount Kisco, New York, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States
Manhattan Behavioral Medicine, PLLC
🇺🇸New York, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
NeuroScience Research Center, LLC.
🇺🇸Canton, Ohio, United States
Carolina Institute for Clinical Research
🇺🇸Fayetteville, North Carolina, United States
Clinical Inquest Center, Ltd
🇺🇸Beavercreek, Ohio, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Central States Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
DiscoveResearch, Inc. (DRI)
🇺🇸Bryan, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Woodstock Research Center
🇺🇸Woodstock, Vermont, United States
Chatham-Kent Clinical Trials Research Centre
🇨🇦Chatham, Ontario, Canada
Queen's University
🇨🇦Kingston, Ontario, Canada
ASST FBF SACCO - Ospedale Universitario Luigi Sacco
🇮🇹Milan, Italy
University of Turin - university hospital san luigi gonzaga
🇮🇹Turin, Italy
Amsterdam UMC, locatie AMC
🇳🇱Amsterdam, Netherlands
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Leiden University Medical Center (LUMC)
🇳🇱Leiden, Netherlands
Surrey and Borders Partnership NHS Foundation Trust
🇬🇧Chertsey, United Kingdom
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
Centro de Salud Mental La Corredoria
🇪🇸Oviedo, Spain
Bioluminux Ltd
🇬🇧Milton Keynes, United Kingdom
Centro de Salud San Juan
🇪🇸Salamanca, Spain
MAC Clinical Research-Lancashire
🇬🇧Blackpool, United Kingdom
MAC Clinical Research -- Merseyside
🇬🇧Liverpool, United Kingdom
MAC Clinical Research-Greater Manchester
🇬🇧Manchester, United Kingdom
South West London and St George's Mental Health NHS Trust Springfield University Hospital
🇬🇧London, United Kingdom
MAC Clinical Research-- South Yorkshire
🇬🇧Tankersley, United Kingdom
Olympian Clinical Research
🇺🇸Tampa, 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
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Michigan Clinical Research Institute PC
🇺🇸Ann Arbor, Michigan, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida Department of Psychiatry
🇺🇸Gainesville, Florida, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
BioBehavioral Research of Austin
🇺🇸Austin, Texas, United States
Greater Manchester Mental Health NHS Foundation Trust
🇬🇧Manchester, United Kingdom