Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:

A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04708834
• Other study ID #: BHV4157-209
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: March 30, 2021
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• Troriluzole (BHV-4157)
200 mg daily first 2 weeks, 280 daily for following 46 weeks

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Chatham-Kent Clinical Trials Research Centre	Chatham	Ontario
Canada	McMaster University, Hamilton Health Sciences	Hamilton	Ontario
Canada	Queen's University	Kingston	Ontario
Canada	START Clinic for Mood and Anxiety Disorders	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University of Toronto / Centre for Addiction and Mental Health (CAMH)	Toronto	Ontario
Italy	Institute of Neuroscience, University of Firenze	Florence
Italy	ASST FBF SACCO - Ospedale Universitario Luigi Sacco	Milan
Italy	University School of Medicine of Napoli Federico II	Naples
Italy	University of Pisa	Pisa
Italy	University of Turin - university hospital san luigi gonzaga	Turin
Netherlands	Amsterdam UMC, locatie AMC	Amsterdam
Netherlands	Leiden University Medical Center (LUMC)	Leiden
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Centro de Salud Mental La Corredoria	Oviedo
Spain	Centro de Salud San Juan	Salamanca
Spain	Hospital Álvaro Cunqueiro	Vigo
United Kingdom	MAC Clinical Research-Lancashire	Blackpool
United Kingdom	Surrey and Borders Partnership NHS Foundation Trust	Chertsey
United Kingdom	MAC Clinical Research -- Merseyside	Liverpool
United Kingdom	South West London and St George's Mental Health NHS Trust Springfield University Hospital	London
United Kingdom	Greater Manchester Mental Health NHS Foundation Trust	Manchester
United Kingdom	MAC Clinical Research-Greater Manchester	Manchester
United Kingdom	Bioluminux Ltd	Milton Keynes
United Kingdom	MAC Clinical Research-- South Yorkshire	Tankersley
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Michigan Clinical Research Institute PC	Ann Arbor	Michigan
United States	Topaz Clinical Research	Apopka	Florida
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	BioBehavioral Research of Austin	Austin	Texas
United States	Northern Light Acadia Hospital	Bangor	Maine
United States	Inquest Clinical Research	Baytown	Texas
United States	Clinical Inquest Center, Ltd	Beavercreek	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	CITrials (Clinical Innovations)	Bellflower	California
United States	Hassman Research Institute	Berlin	New Jersey
United States	Southern California Research, LLC	Beverly Hills	California
United States	Boca Raton Medical Institute	Boca Raton	Florida
United States	Northwest Clinical Trials	Boise	Idaho
United States	Boston Clinical Trials	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Integrative Clinical Trials, LLC	Brooklyn	New York
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	DiscoveResearch, Inc. (DRI)	Bryan	Texas
United States	NeuroScience Research Center, LLC.	Canton	Ohio
United States	Neurobehavioral Research, Inc	Cedarhurst	New York
United States	Metropolitan Neuro Behavioral Institute	Chandler	Arizona
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	University of Chicago Department of Psychiatry & Behavioral Neuroscience	Chicago	Illinois
United States	Uptown Research Institute	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Axiom Research, LLC	Colton	California
United States	Advanced Clinical Research Network	Coral Gables	Florida
United States	CNS Research of Coral Springs	Coral Springs	Florida
United States	Global Clinical Trials	Costa Mesa	California
United States	ProScience Research Group	Culver City	California
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Relaro Medical Trials	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Mountain View Clinical Research	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	Revive Research Institute	Elgin	Illinois
United States	WR-PRI, LLC (Encino)	Encino	California
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Precise Research Centers	Flowood	Mississippi
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	North Texas Clinical Trials	Fort Worth	Texas
United States	University of Florida Department of Psychiatry	Gainesville	Florida
United States	CBH Health	Gaithersburg	Maryland
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Bio Behavioral Institute	Great Neck	New York
United States	Institute of Living / Hartford Hospital	Hartford	Connecticut
United States	Galiz Research	Hialeah	Florida
United States	Health Care Family Rehab & Research	Hialeah	Florida
United States	Qway Research, LLC	Hialeah	Florida
United States	Research in Miami Inc	Hialeah	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Clinical Trial Network	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Sun Valley Research Center, Inc.	Imperial	California
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Accel Research Sites (formerly Meridien Research)	Lakeland	Florida
United States	Om Research LLC	Lancaster	California
United States	Altea Research	Las Vegas	Nevada
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	Synergy Research San Diego	Lemon Grove	California
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Atria Clinical Research	Little Rock	Arkansas
United States	Alliance for Research	Long Beach	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	CalNeuro Research Group	Los Angeles	California
United States	Clarity Clinical Research	Los Angeles	California
United States	Pharmaceutical Research Center, Inc.	Lutz	Florida
United States	ClinCloud, LLC	Maitland	Florida
United States	Meridien Research	Maitland	Florida
United States	Suburban Research Associates	Media	Pennsylvania
United States	SMS Clinical Research	Mesquite	Texas
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	Central Miami Medical Institute	Miami	Florida
United States	Clintex Research	Miami	Florida
United States	Ezy Medical Research, Co.	Miami	Florida
United States	FIRC	Miami	Florida
United States	Florida Research Center, Inc.	Miami	Florida
United States	Med-Care Research	Miami	Florida
United States	Miami Dade Medical Research Institute	Miami	Florida
United States	Sanchez Clinical Research Inc	Miami	Florida
United States	Pro-Care Research Center	Miami Gardens	Florida
United States	South Florida Research Phase I-IV, Inc.	Miami Springs	Florida
United States	Boeson Research	Missoula	Montana
United States	Mt.Olympus Medical Research LLC	Missouri City	Texas
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	AMR-Baber Research, Inc	Naperville	Illinois
United States	Advanced Research for Health Improvement	Naples	Florida
United States	Yale University	New Haven	Connecticut
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Bayside Clinical Research, LLC	New Port Richey	Florida
United States	Hapworth Research	New York	New York
United States	Manhattan Behavioral Medicine, PLLC	New York	New York
United States	New York State Psychiatric Institute	New York	New York
United States	Pharmacology Research Institute (WR-PRI, LLC)	Newport Beach	California
United States	Bravo Health Care Center	North Bay Village	Florida
United States	Behavioral Clinical Research	North Miami	Florida
United States	Harmony Clinical Research	North Miami Beach	Florida
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Psychiatric Care and Research Center	O'Fallon	Missouri
United States	Pacific Research Partners	Oakland	California
United States	Excell Research, Inc	Oceanside	California
United States	North County Clinical Research	Oceanside	California
United States	IPS Research	Oklahoma City	Oklahoma
United States	NRC Research Institute	Orange	California
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	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Alea Research	Phoenix	Arizona
United States	NoeisisPharma, LLC	Phoenix	Arizona
United States	Pharmasite Research, Inc.	Pikesville	Maryland
United States	DMI Research	Pinellas Park	Florida
United States	AIM Trials	Plano	Texas
United States	Collective Medical Research	Prairie Village	Kansas
United States	Anderson Clinical Research	Redlands	California
United States	CI Trials	Riverside	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	ACRC Studies	San Diego	California
United States	Lumos Clinical Research Center, LLC	San Jose	California
United States	National Research Institute	Santa Ana	California
United States	iResearch Savannah	Savannah	Georgia
United States	California Neuroscience Research Medical Group, Inc	Sherman Oaks	California
United States	Renew Health Clinical Research, LLC	Snellville	Georgia
United States	Sisu at RMG	Springfield	Massachusetts
United States	Stanford University	Stanford	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Lenus Research & Medical Group, LLC	Sweetwater	Florida
United States	Olympian Clinical Research	Tampa	Florida
United States	Stedman Clinical Trials	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Collaborative Neuroscience Research	Torrance	California
United States	Continental Clinical Solutions, LLC	Towson	Maryland
United States	Central States Research, LLC	Tulsa	Oklahoma
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Adams Clinical	Watertown	Massachusetts
United States	Grayline Research Center	Wichita Falls	Texas
United States	Conquest Research LLC	Winter Park	Florida
United States	Woodstock Research Center	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.	Change from Baseline to week 48