Clinical trial NCT04641143: Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
OCD
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

1. 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
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 as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
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 trial as designed

Exclusion Criteria:

1. 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.
2. 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
3. Previous treatment in a study with troriluzole

Primary outcomes:
measure: The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10
Secondary outcomes:
measure: Frequency of SAEs and AEs leading to discontinuation
timeFrame: From Screening through study completion, up to 10 weeks
measure: Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)
timeFrame: From baseline through study completion (up to 10 weeks)
measure: Improvement in global functioning responses assessed on the CGI-I scale.
timeFrame: From baseline through study completion (up to 10 weeks)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Metropolitan Neuro Behavioral Institute
state: Arizona
city: Phoenix
country: United States
facility: IMA Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: NoeisisPharma, LLC
state: Arizona
city: Little Rock
country: United States
facility: Atria Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Bellflower
country: United States
facility: CITrials (Clinical Innovations)
state: California
city: Colton
country: United States
facility: Axiom Research, LLC
state: California
city: Costa Mesa
country: United States
facility: Global Clinical Trials
state: California
city: Encino
country: United States
facility: WR-PRI, LLC (Encino)
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy Research San Diego
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: Clarity Clinical Research
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (WR-PRI, LLC)
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: ACRC Studies
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center, LLC
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research
state: California
city: New Haven
country: United States
facility: Yale University / Connecticut Mental Health Center
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Medical Institute
state: Florida
city: Coral Gables
country: United States
facility: Advanced Clinical Research Network
state: Florida
city: Hialeah
country: United States
facility: Research in Miami Inc
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Miami Gardens
country: United States
facility: Pro-Care Research Center
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV , Inc.
state: Florida
city: Miami
country: United States
facility: Health Care Family Rehab & Research
state: Florida
city: Miami
country: United States
facility: Central Miami Medical Institute
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: FIRC
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Bayside Clinical Research, LLC
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Orlando
country: United States
facility: APG Research, LLC
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC Inc
state: Florida
city: Pembroke Pines
country: United States
facility: MedBio Trials
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Winter Park
country: United States
facility: Conquest Research LLC
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Savannah
country: United States
facility: iResearch Savannah
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Elgin
country: United States
facility: Revive Research Institute
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research, Inc
state: Illinois
city: Overland Park
country: United States
facility: Collective Medical Research
state: Kansas
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Pikesville
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Springfield
country: United States
facility: Sisu at RMG
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute PC
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials, LLC
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc
state: New York
city: Great Neck
country: United States
facility: Bio Behavioral Institute
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: Hapworth Research
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Beavercreek
country: United States
facility: Clinical Inquest Center, Ltd
state: Ohio
city: Canton
country: United States
facility: NeuroScience Research Center, LLC.
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Tulsa
country: United States
facility: Central States Research, LLC
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Providence
country: United States
facility: Comprehensive Psychiatric Care Providers
state: Rhode Island
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc. (DRI)
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: Fort Worth
country: United States
facility: North Texas Clinical Trials
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Missouri City
country: United States
facility: Mt.Olympus Medical Research LLC
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
References: