Efficacy and Safety Study of Adjunctive Troriluzole 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: NCT04641143
• Other study ID #: BHV4157-302
• Status: Recruiting
• Phase: Phase 3
• Start date: December 22, 2020
• Est. completion date: December 2024

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 is 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: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Drug:
• Troriluzole
Troriluzole - 2 100mg capsules QD for the first two weeks.
• Placebo
Matching placebo - 2 140mg capsules QD from week two through week ten.

Locations

Country	Name	City	State
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Michigan Clinical Research Institute PC	Ann Arbor	Michigan
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	BioBehavioral Research of Austin	Austin	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	Boca Raton Medical Institute	Boca Raton	Florida
United States	Northwest Clinical Trials	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Integrative 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	Uptown Research Institute	Chicago	Illinois
United States	Axiom Research, LLC	Colton	California
United States	Advanced Clinical Research Network	Coral Gables	Florida
United States	Global Clinical Trials	Costa Mesa	California
United States	Relaro Medical Trials	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Revive Research Institute	Elgin	Illinois
United States	WR-PRI, LLC (Encino)	Encino	California
United States	Precise Research Centers	Flowood	Mississippi
United States	North Texas Clinical Trials	Fort Worth	Texas
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	Galiz Research	Hialeah	Florida
United States	Research in Miami Inc	Hialeah	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Accel Research Sites	Lakeland	Florida
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	Pharmacology Research Institute	Los Alamitos	California
United States	Clarity Clinical Research	Los Angeles	California
United States	ClinCloud, LLC	Maitland	Florida
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	FIRC	Miami	Florida
United States	Florida Research Center, Inc.	Miami	Florida
United States	Health Care Family Rehab & Research	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	Mt.Olympus Medical Research LLC	Missouri City	Texas
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	Yale University / Connecticut Mental Health Center	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	Pharmacology Research Institute (WR-PRI, LLC)	Newport Beach	California
United States	Behavioral Clinical Research	North Miami	Florida
United States	Pacific Research Partners	Oakland	California
United States	Excell Research, Inc	Oceanside	California
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	NoeisisPharma, LLC	Phoenix	Arizona
United States	Pharmasite Research, Inc.	Pikesville	Maryland
United States	Comprehensive Psychiatric Care Providers	Providence	Rhode Island
United States	Anderson Clinical Research	Redlands	California
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	ACRC Studies	San Diego	California
United States	iResearch Savannah	Savannah	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	Stedman Clinical Trials	Tampa	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Collaborative Neuroscience Research	Torrance	California
United States	Central States Research, LLC	Tulsa	Oklahoma
United States	Grayline Research Center	Wichita Falls	Texas
United States	Conquest Research LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total score on the Yale-Brown Obsessive Compulsive Scale (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 to discontinuation	Percent difference between troriluzole vs placebo treatment emergent adverse events.	From Screening through study completion, up to 10 weeks
Secondary	Improvement in functional disability as assessed by the change in 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 assessed on the CGI-I scale.	Change is measured as "much improved" or "very much improved" on the CGII scale	From baseline through study completion (up to 10 weeks)