Clinical trial NCT04693351: Efficacy and Safety Study of Adjunctive Troriluzule 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: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder (OCD)
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-05
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 its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)


Eligibility criteria: Key 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 subjects illness must be ≥ 1year
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 too current standard of car base on the YBOCS score.
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 trail as designed.

Key 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 autism 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 Disorder (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 discontinuation
timeFrame: From Screening through Study completion, up to 10 weeks
measure: Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)
timeFrame: From baseline through study completion (up to 10 weeks)
measure: Improvement in global functioning responses as assessed on the CGI-I scale.
timeFrame: From baseline through study completion (up to 10 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alea Research
state: Arizona
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: La Jolla
country: United States
facility: Kaizen Brain Center
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Angeles
country: United States
facility: CalNeuro Research Group
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center, LLC
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Apopka
country: United States
facility: Topaz Clinical Research
state: Florida
city: Coral Springs
country: United States
facility: CNS Research of Coral Springs
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida Department of Psychiatry
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research, Co.
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research
state: Florida
city: Palm Beach
country: United States
facility: dTMS Center LLC
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Decatur
country: United States
facility: CenExel iResearch
state: Georgia
city: Snellville
country: United States
facility: Renew Health Clinical Research, LLC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Department of Psychiatry & Behavioral Neuroscience
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: Towson
country: United States
facility: Continental Clinical Solutions, LLC
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: Raleigh
country: United States
facility: Richard H. Weisler, MD PA & Associates
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Dayton
country: United States
facility: American Clinical Research Institute (ACRI)
state: Ohio
city: Kettering
country: United States
facility: American Research Institute (ACRI)
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Austin
country: United States
facility: Donald J. Garcia Jr., MD PA
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Woodstock
country: United States
facility: Woodstock Research Center
state: Vermont
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials Research Centre
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University, Hamilton Health Sciences
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: START Clinic for Mood and Anxiety Disorders
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto / Centre for Addiction and Mental Health (CAMH)
state: Ontario
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
state: Changping District
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Haidian District
city: Hangzhou
country: China
facility: Hangzhou Seventh People's Hospital
state: Hangzhou City
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Hexi District
city: Xiangya
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Minhang District
city: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Qiaokou District
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Tianhe District
city: Chengdu
country: China
facility: Mental Health Center, West China Hospital, Sichuan University
state: Wuhou District
city: Shijiazhuang
country: China
facility: First Hospital of Hebei Medical University
state: Yuhua District
city: Milan
country: Italy
facility: ASST FBF SACCO - Ospedale Universitario Luigi Sacco
city: Naples
country: Italy
facility: University School of Medicine of Napoli Federico II
city: Pisa
country: Italy
facility: University of Pisa
city: Turin
country: Italy
facility: University of Turin - university hospital san luigi gonzaga
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Oviedo
country: Spain
facility: Centro de Salud Mental La Corredoria
city: Salamanca
country: Spain
facility: Centro de Salud San Juan
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Stockton-on-Tees
country: United Kingdom
facility: MAC Clinical Research
state: County Durham
city: Stony Stratford
country: United Kingdom
facility: Stemax Consult - Healthcare Services Ltd
state: Northamptonshire
city: Cannock
country: United Kingdom
facility: MAC Clinical Research - South Staffordshire
state: South Staffordshire
city: Blackpool
country: United Kingdom
facility: MAC Clinical Research-Lancashire
city: Leeds
country: United Kingdom
facility: MAC Clinical Research
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research -- Merseyside
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
city: Milton Keynes
country: United Kingdom
facility: Bioluminux Ltd
city: Swindon
country: United Kingdom
facility: Kingshill Research Centre
city: Tankersley
country: United Kingdom
facility: MAC Clinical Research-- South Yorkshire
Study officials:
References: