Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04693351
• Other study ID #: BHV4157-303
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2021
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: Chief Medical Officer
• Phone: 203-404-0410
• Email: clinicaltrials[@]biohavenpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Drug:
• Troriluzole
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
• Placebo
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.

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
China	Beijing HuiLongGuan Hospital	Beijing	Changping District
China	Peking University Sixth Hospital	Beijing	Haidian District
China	Mental Health Center, West China Hospital, Sichuan University	Chengdu	Wuhou District
China	The First Affiliated Hospital of Jinan University	Guangzhou	Tianhe District
China	Hangzhou Seventh People's Hospital	Hangzhou	Hangzhou City
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Shanghai Mental Health Center	Shanghai	Minhang District
China	First Hospital of Hebei Medical University	Shijiazhuang	Yuhua District
China	Tianjin Anding Hospital	Tianjin	Hexi District
China	Wuhan Mental Health Center	Wuhan	Qiaokou District
China	The Second Xiangya Hospital of Central South University	Xiangya	Hunan
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
Puerto Rico	Barbara Diaz Hernandez MD Research, Inc.	San Juan
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	MAC Clinical Research - South Staffordshire	Cannock	South Staffordshire
United Kingdom	Surrey and Borders Partnership NHS Foundation Trust	Chertsey
United Kingdom	MAC Clinical Research	Leeds
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	Bioluminux Ltd	Milton Keynes
United Kingdom	MAC Clinical Research	Stockton-on-Tees	County Durham
United Kingdom	Stemax Consult - Healthcare Services Ltd	Stony Stratford	Northamptonshire
United Kingdom	Kingshill Research Centre	Swindon
United Kingdom	MAC Clinical Research-- South Yorkshire	Tankersley
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Topaz Clinical Research	Apopka	Florida
United States	Donald J. Garcia Jr., MD PA	Austin	Texas
United States	Inquest Clinical Research	Baytown	Texas
United States	Boston Clinical Trials	Boston	Massachusetts
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	University of Chicago Department of Psychiatry & Behavioral Neuroscience	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	CNS Research of Coral Springs	Coral Springs	Florida
United States	ProScience Research Group	Culver City	California
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	American Clinical Research Institute (ACRI)	Dayton	Ohio
United States	Neurology Diagnostics, Inc.	Dayton	Ohio
United States	CenExel iResearch	Decatur	Georgia
United States	Mountain View Clinical Research	Denver	Colorado
United States	InSite Clinical Research	DeSoto	Texas
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	NovoTrial Research Group	Frisco	Texas
United States	University of Florida Department of Psychiatry	Gainesville	Florida
United States	Institute of Living / Hartford Hospital	Hartford	Connecticut
United States	Qway Research, LLC	Hialeah	Florida
United States	Clinical Trial Network	Houston	Texas
United States	ARSMNC	Huntersville	North Carolina
United States	Sun Valley Research Center, Inc.	Imperial	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	American Research Institute (ACRI)	Kettering	Ohio
United States	Kaizen Brain Center	La Jolla	California
United States	Om Research LLC	Lancaster	California
United States	ASCLEPES ResearchCEnters, P.C.	Long Beach	California
United States	CalNeuro Research Group	Los Angeles	California
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clintex Research	Miami	Florida
United States	Ezy Medical Research, Co.	Miami	Florida
United States	Med-Care Research	Miami	Florida
United States	Miami Dade Medical Research Institute	Miami	Florida
United States	North Star Medical Research, LLC	Middleburg Heights	Ohio
United States	Boeson Research	Missoula	Montana
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	Riverstar Research	New Orleans	Louisiana
United States	Manhattan Behavioral Medicine, PLLC	New York	New York
United States	Bravo Health Care Center	North Bay Village	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	North County Clinical Research	Oceanside	California
United States	IPS Research	Oklahoma City	Oklahoma
United States	Collective Medical Research	Overland Park	Kansas
United States	dTMS Center LLC	Palm Beach	Florida
United States	Alea Research	Phoenix	Arizona
United States	DMI Research	Pinellas Park	Florida
United States	AIM Trials	Plano	Texas
United States	Richard H. Weisler, MD PA & Associates	Raleigh	North Carolina
United States	CI Trials	Riverside	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Lumos Clinical Research Center, LLC	San Jose	California
United States	Velocity Clinical Research	Santa Ana	California
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Renew Health Clinical Research, LLC	Snellville	Georgia
United States	Olympian Clinical Research	Tampa	Florida
United States	Continental Clinical Solutions, LLC	Towson	Maryland
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Adams Clinical	Watertown	Massachusetts
United States	Woodstock Research Center	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  China,  Italy,  Netherlands,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS)	Improvement is measured by a lower total score	Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10
Secondary	Frequency of SAEs and AEs leading discontinuation	Percent difference between troriluzole vs placebo treatment emergent adverse events	From Screening through Study completion, up to 10 weeks
Secondary	Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)	Change is measured as "mild" or "moderate" on the SDS	From baseline through study completion (up to 10 weeks)
Secondary	Improvement in global functioning responses as assessed on the CGI-I scale.	Change is measured as "much improved" or very much improved" on the CGI-I scale.	From baseline through study completion (up to 10 weeks)