Clinical trial NCT04708834: Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
Official title: A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive compulsive disorder
OCD
troriluzole
Biohaven
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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;

Primary outcomes:
measure: 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
timeFrame: Change from Baseline to week 240
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Metropolitan Neuro Behavioral Institute
state: Arizona
city: Phoenix
country: United States
facility: Alea 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: Beverly Hills
country: United States
facility: Southern California Research, LLC
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: Culver City
country: United States
facility: ProScience Research Group
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: Imperial
country: United States
facility: Sun Valley Research Center, Inc.
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy Research San Diego
state: California
city: Long Beach
country: United States
facility: Alliance for Research
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Los Angeles
country: United States
facility: CalNeuro Research Group
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: North County Clinical Research
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: Riverside
country: United States
facility: CI Trials
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: Santa Ana
country: United States
facility: National Research Institute
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: 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: Hartford
country: United States
facility: Institute of Living / Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
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: Apopka
country: United States
facility: Topaz Clinical Research
state: Florida
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: 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: Hialeah
country: United States
facility: Qway Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Research in Miami Inc
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab & Research
state: Florida
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites (formerly Meridien Research)
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Lutz
country: United States
facility: Pharmaceutical Research Center, Inc.
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Maitland
country: United States
facility: Meridien Research
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: Central Miami Medical Institute
state: Florida
city: Miami
country: United States
facility: Clintex Research
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Miami
country: United States
facility: FIRC
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research, Co.
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement
state: Florida
city: New Port Richey
country: United States
facility: Bayside Clinical Research, LLC
state: Florida
city: North Bay Village
country: United States
facility: Bravo Health Care Center
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research
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: Pinellas Park
country: United States
facility: DMI Research
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: Tampa
country: United States
facility: Olympian Clinical Research
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: Snellville
country: United States
facility: Renew Health Clinical Research, LLC
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: Chicago
country: United States
facility: University of Chicago Department of Psychiatry & Behavioral Neuroscience
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: Prairie Village
country: United States
facility: Collective Medical Research
state: Kansas
city: Bangor
country: United States
facility: Northern Light Acadia Hospital
state: Maine
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Pikesville
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Towson
country: United States
facility: Continental Clinical Solutions, LLC
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: Watertown
country: United States
facility: Adams Clinical
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: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
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: Brooklyn
country: United States
facility: SPRI 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: New York State Psychiatric Institute
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine, PLLC
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
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: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Tulsa
country: United States
facility: Central States Research, LLC
state: Oklahoma
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: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: BioBehavioral Research of Austin
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc. (DRI)
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Dallas
country: United States
facility: Relaro Medical Trials
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
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: Clinical Trial Network
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: Plano
country: United States
facility: AIM Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Woodstock
country: United States
facility: Woodstock Research Center
state: Vermont
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
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: Florence
country: Italy
facility: Institute of Neuroscience, University of Firenze
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: Blackpool
country: United Kingdom
facility: MAC Clinical Research-Lancashire
city: Chertsey
country: United Kingdom
facility: Surrey and Borders Partnership NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: MAC Clinical Research -- Merseyside
city: London
country: United Kingdom
facility: South West London and St George's Mental Health NHS Trust Springfield University Hospital
city: Manchester
country: United Kingdom
facility: MAC Clinical Research-Greater Manchester
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
city: Milton Keynes
country: United Kingdom
facility: Bioluminux Ltd
city: Tankersley
country: United Kingdom
facility: MAC Clinical Research-- South Yorkshire
Study officials:
References: