A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Who is this study for? Patients with obsessive-compulsive disorder
What treatments are being studied? Troriluzole
Status: Active_not_recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Metropolitan Neuro Behavioral Institute
Chandler
IMA Clinical Research
Phoenix
NoeisisPharma, LLC
Phoenix
California
CITrials (Clinical Innovations)
Bellflower
Axiom Research, LLC
Colton
WR-PRI, LLC (Encino)
Encino
Behavioral Research Specialists, LLC
Glendale
Pharmacology Research Institute
Los Alamitos
Clarity Clinical Research
Los Angeles
Excell Research, Inc
Oceanside
NRC Research Institute
Orange
Anderson Clinical Research
Redlands
Lumos Clinical Research Center, LLC
San Jose
California Neuroscience Research Medical Group, Inc
Sherman Oaks
Stanford University
Stanford
Collaborative Neuroscience Research
Torrance
Connecticut
Yale University / Connecticut Mental Health Center
New Haven
Comprehensive Psychiatric Care
Norwich
Florida
Boca Raton Medical Institute
Boca Raton
Advanced Clinical Research Network
Coral Gables
Research in Miami Inc
Hialeah
Accel Research Sites
Lakeland
Innovative Clinical Research, Inc.
Lauderhill
Central Miami Medical Institute
Miami
FIRC
Miami
Florida Research Center, Inc.
Miami
Health Care Family Rehab & Research
Miami
South Florida Research Phase I-IV , Inc.
Miami Springs
Behavioral Clinical Research
North Miami
Medical Research Group of Central Florida
Orange City
APG Research, LLC
Orlando
Combined Research Orlando Phase I-IV
Orlando
Omega Research Consultants
Orlando
MedBio Trials
Pembroke Pines
Stedman Clinical Trials
Tampa
Neurobehaviorial Institute
Weston
Conquest Research LLC
Winter Park
Georgia
iResearch Atlanta, LLC
Decatur
iResearch Savannah
Savannah
Idaho
Northwest Clinical Trials
Boise
Illinois
Uptown Research Institute
Chicago
Revive Research Institute
Elgin
AMR-Baber Research, Inc
Naperville
Kansas
Collective Medical Research
Overland Park
Massachusetts
Boston Clinical Trials
Boston
Massachusetts General Hospital
Boston
ActivMed Practices and Research
Methuen
Sisu at RMG
Springfield
Maryland
CBH Health
Gaithersburg
Pharmasite Research, Inc.
Pikesville
Michigan
Michigan Clinical Research Institute PC
Ann Arbor
Missouri
Psychiatric Care and Research Center
O'fallon
Mississippi
Precise Research Centers
Flowood
New Jersey
Hassman Research Institute
Berlin
Bio Behavioral Health
Toms River
Nevada
Altea Research
Las Vegas
New York
Integrative Clinical Trials, LLC
Brooklyn
Neurobehavioral Research, Inc
Cedarhurst
Bio Behavioral Institute
Great Neck
Bioscience Research, LLC
Mount Kisco
Manhattan Behavioral Medicine, PLLC
New York
Richmond Behavioral Associates
Staten Island
Ohio
Clinical Inquest Center, Ltd
Beavercreek
Oklahoma
Central States Research, LLC
Tulsa
Pennsylvania
Suburban Research Associates
Media
Rhode Island
Comprehensive Psychiatric Care Providers
Providence
Texas
BioBehavioral Research of Austin
Austin
Relaro Medical Trials
Dallas
North Texas Clinical Trials
Fort Worth
Baylor College of Medicine
Houston
Texas Center for Drug Development, Inc.
Houston
Mt.Olympus Medical Research LLC
Missouri City
Washington
Northwest Clinical Research Center
Bellevue
Time Frame
Start Date: 2020-12-22
Completion Date: 2025-11
Participants
Target number of participants: 700
Treatments
Active_comparator: 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_comparator: Placebo
Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
Related Therapeutic Areas
Sponsors
Leads: Biohaven Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov