Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder
- Registration Number
- NCT04641143
- Lead Sponsor
- Biohaven Pharmaceuticals, Inc.
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
- 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
- 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
- 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
- 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.
- 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
- Previous treatment in a study with troriluzole
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Troriluzole Troriluzole Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten. Placebo Placebo Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
- Primary Outcome Measures
Name Time Method The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS) Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10 Improvement is measured by a lower total score
- Secondary Outcome Measures
Name Time Method Frequency of SAEs and AEs leading to discontinuation From Screening through study completion, up to 10 weeks Percent difference between troriluzole vs placebo treatment emergent adverse events.
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS) From baseline through study completion (up to 10 weeks) Change is measured as "mild" or "moderate" on the SDS
Improvement in global functioning responses assessed on the CGI-I scale. From baseline through study completion (up to 10 weeks) Change is measured as "much improved" or "very much improved" on the CGII scale
Trial Locations
- Locations (249)
Metropolitan Neuro Behavioral Institute
🇺🇸Chandler, Arizona, United States
IMA Clinical Research
🇺🇸Phoenix, Arizona, United States
Atria Clinical Research
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
CITrials (Clinical Innovations)
🇺🇸Bellflower, California, United States
Global Clinical Trials
🇺🇸Costa Mesa, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Synergy Research San Diego
🇺🇸Lemon Grove, California, United States
Pharmacology Research Institute (WR-PRI, LLC)
🇺🇸Newport Beach, California, United States
Pacific Research Partners
🇺🇸Oakland, California, United States
ACRC Studies
🇺🇸San Diego, California, United States
Lumos Clinical Research Center, LLC
🇺🇸San Jose, California, United States
California Neuroscience Research Medical Group, Inc
🇺🇸Sherman Oaks, California, United States
Coastal Connecticut Research, LLC
🇺🇸New London, 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
Galiz Research
🇺🇸Hialeah, Florida, United States
Accel Research Sites
🇺🇸Lakeland, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
Pro-Care Research Center
🇺🇸Miami Gardens, Florida, United States
Sanchez Clinical Research Inc
🇺🇸Miami, Florida, United States
Bayside Clinical Research, LLC
🇺🇸New Port Richey, Florida, United States
IMIC Inc
🇺🇸Palmetto Bay, Florida, United States
MedBio Trials
🇺🇸Pembroke Pines, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
AMR-Baber Research, Inc
🇺🇸Naperville, Illinois, United States
Collective Medical Research
🇺🇸Overland Park, Kansas, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Bio Behavioral Institute
🇺🇸Great Neck, New York, United States
Hapworth Research
🇺🇸New York, New York, United States
Manhattan Behavioral Medicine, PLLC
🇺🇸New York, New York, United States
Clinical Inquest Center, Ltd
🇺🇸Beavercreek, Ohio, United States
NeuroScience Research Center, LLC.
🇺🇸Canton, Ohio, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
DiscoveResearch, Inc. (DRI)
🇺🇸Bryan, 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
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Mt.Olympus Medical Research LLC
🇺🇸Missouri City, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Comprehensive Psychiatric Care Providers
🇺🇸Providence, Rhode Island, United States
BioBehavioral Research of Austin
🇺🇸Austin, Texas, United States
DiscoveResearch, Inc. (DRI)
🇺🇸Bryan, Texas, United States
NoeisisPharma, LLC
🇺🇸Phoenix, Arizona, United States
Axiom Research, LLC
🇺🇸Colton, California, United States
WR-PRI, LLC (Encino)
🇺🇸Encino, California, United States
Clarity Clinical Research
🇺🇸Los Angeles, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Anderson Clinical Research
🇺🇸Redlands, 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
Research in Miami Inc
🇺🇸Hialeah, Florida, United States
Pharmacology Research Institute (WR-PRI, LLC)
🇺🇸Newport Beach, California, United States
Psychiatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
Metropolitan Neuro Behavioral Institute
🇺🇸Chandler, Arizona, United States
NoeisisPharma, LLC
🇺🇸Phoenix, Arizona, United States
CITrials (Clinical Innovations)
🇺🇸Bellflower, California, United States
IMA Clinical Research
🇺🇸Phoenix, Arizona, United States
Atria Clinical Research
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Axiom Research, LLC
🇺🇸Colton, California, United States
Global Clinical Trials
🇺🇸Costa Mesa, California, United States
WR-PRI, LLC (Encino)
🇺🇸Encino, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Synergy Research San Diego
🇺🇸Lemon Grove, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Clarity Clinical Research
🇺🇸Los Angeles, California, United States
Pacific Research Partners
🇺🇸Oakland, 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
ACRC Studies
🇺🇸San Diego, 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
Coastal Connecticut Research, LLC
🇺🇸New London, 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
Galiz Research
🇺🇸Hialeah, Florida, United States
Accel Research Sites
🇺🇸Lakeland, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
Pro-Care Research Center
🇺🇸Miami Gardens, Florida, United States
South Florida Research Phase I-IV , Inc.
🇺🇸Miami Springs, Florida, United States
Health Care Family Rehab & Research
🇺🇸Miami, Florida, United States
Central Miami Medical Institute
🇺🇸Miami, Florida, United States
Sanchez Clinical Research Inc
🇺🇸Miami, Florida, United States
FIRC
🇺🇸Miami, Florida, United States
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Bayside Clinical Research, LLC
🇺🇸New Port Richey, 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
IMIC Inc
🇺🇸Palmetto Bay, Florida, United States
MedBio Trials
🇺🇸Pembroke Pines, Florida, United States
Lenus Research & Medical Group, LLC
🇺🇸Sweetwater, Florida, United States
Conquest Research LLC
🇺🇸Winter Park, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
NeuroTrials Research Inc
🇺🇸Atlanta, Georgia, 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
Capstone Clinical Research
🇺🇸Libertyville, 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
PsychCare Consultants Research
🇺🇸Saint Louis, 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
Hapworth Research
🇺🇸New York, 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
NeuroScience Research Center, LLC.
🇺🇸Canton, Ohio, United States
Midwest Clinical Research Center
🇺🇸Dayton, 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
DiscoveResearch, Inc. (DRI)
🇺🇸Bryan, 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
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Mt.Olympus Medical Research LLC
🇺🇸Missouri City, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Metropolitan Neuro Behavioral Institute
🇺🇸Chandler, Arizona, United States
IMA Clinical Research
🇺🇸Phoenix, Arizona, United States
NoeisisPharma, LLC
🇺🇸Phoenix, Arizona, United States
Atria Clinical Research
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
CITrials (Clinical Innovations)
🇺🇸Bellflower, California, United States
Axiom Research, LLC
🇺🇸Colton, California, United States
Global Clinical Trials
🇺🇸Costa Mesa, California, United States
WR-PRI, LLC (Encino)
🇺🇸Encino, California, United States
Behavioral Research Specialists, LLC
🇺🇸Glendale, California, United States
Synergy Research San Diego
🇺🇸Lemon Grove, California, United States
Pharmacology Research Institute
🇺🇸Los Alamitos, California, United States
Clarity Clinical Research
🇺🇸Los Angeles, 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
NRC Research Institute
🇺🇸Orange, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
ACRC Studies
🇺🇸San Diego, 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
Coastal Connecticut Research, LLC
🇺🇸New London, 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
Galiz Research
🇺🇸Hialeah, Florida, United States
Accel Research Sites
🇺🇸Lakeland, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
Pro-Care Research Center
🇺🇸Miami Gardens, Florida, United States
South Florida Research Phase I-IV , Inc.
🇺🇸Miami Springs, Florida, United States
Health Care Family Rehab & Research
🇺🇸Miami, Florida, United States
Central Miami Medical Institute
🇺🇸Miami, Florida, United States
Sanchez Clinical Research Inc
🇺🇸Miami, Florida, United States
FIRC
🇺🇸Miami, Florida, United States
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Bayside Clinical Research, LLC
🇺🇸New Port Richey, 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
IMIC Inc
🇺🇸Palmetto Bay, Florida, United States
MedBio Trials
🇺🇸Pembroke Pines, Florida, United States
Lenus Research & Medical Group, LLC
🇺🇸Sweetwater, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, 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
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Revive Research Institute
🇺🇸Elgin, Illinois, United States
Capstone Clinical Research
🇺🇸Libertyville, 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
PsychCare Consultants Research
🇺🇸Saint Louis, 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
Hapworth Research
🇺🇸New York, 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
NeuroScience Research Center, LLC.
🇺🇸Canton, Ohio, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Central States Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, 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
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Mt.Olympus Medical Research LLC
🇺🇸Missouri City, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States