Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT04693351
- Lead Sponsor
- Biohaven Pharmaceuticals, Inc.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 700
- 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
- 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.
- 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
- 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.
- 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.
- Previous treatment in a study with troriluzole
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo- 2 100mg capsules once daily for the first two weeks. Placebo- 2 140mg capsules once daily from week two through week ten. Troriluzole Troriluzole Troriluzole- 2 100mg capsules once daily for the first two weeks. Troriluzole- 2 140mg capsules once daily from week two through week ten.
- Primary Outcome Measures
Name Time Method The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS) Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10 Improvement is measured by a lower total score
- Secondary Outcome Measures
Name Time Method Improvement in global functioning responses as assessed on the CGI-I scale. From baseline through study completion (up to 10 weeks) Change is measured as "much improved" or very much improved" on the CGI-I scale.
Frequency of SAEs and AEs leading discontinuation From Screening through Study completion, up to 10 weeks Percent difference between troriluzole vs placebo treatment emergent adverse events
Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS) From baseline through study completion (up to 10 weeks) Change is measured as "mild" or "moderate" on the SDS
Trial Locations
- Locations (88)
Alea Research
🇺🇸Phoenix, Arizona, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Kaizen Brain Center
🇺🇸La Jolla, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
CalNeuro Research Group
🇺🇸Los Angeles, California, 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
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Topaz Clinical Research
🇺🇸Apopka, Florida, United States
CNS Research of Coral Springs
🇺🇸Coral Springs, Florida, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
University of Florida Department of Psychiatry
🇺🇸Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Med-Care Research
🇺🇸Miami, Florida, United States
Ezy Medical Research, Co.
🇺🇸Miami, Florida, United States
Advanced Research for Health Improvement
🇺🇸Naples, Florida, United States
Harmony Clinical Research
🇺🇸North Miami Beach, Florida, United States
dTMS Center LLC
🇺🇸Palm Beach, Florida, United States
DMI Research
🇺🇸Pinellas Park, Florida, United States
CenExel iResearch
🇺🇸Decatur, Georgia, United States
Renew Health Clinical Research, LLC
🇺🇸Snellville, Georgia, United States
University of Chicago Department of Psychiatry & Behavioral Neuroscience
🇺🇸Chicago, Illinois, United States
AMR-Baber Research, Inc.
🇺🇸Naperville, Illinois, United States
Collective Medical Research
🇺🇸Overland Park, Kansas, United States
Continental Clinical Solutions, LLC
🇺🇸Towson, Maryland, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Psychiatric Care and Research Center
🇺🇸O'Fallon, Missouri, United States
Boeson Research
🇺🇸Missoula, Montana, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Manhattan Behavioral Medicine, PLLC
🇺🇸New York, New York, United States
Richard H. Weisler, MD PA & Associates
🇺🇸Raleigh, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
American Clinical Research Institute (ACRI)
🇺🇸Dayton, Ohio, United States
American Research Institute (ACRI)
🇺🇸Kettering, Ohio, United States
North Star Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Donald J. Garcia Jr., MD PA
🇺🇸Austin, Texas, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
FutureSearch Trials of Dallas, LP
🇺🇸Dallas, Texas, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
AIM Trials
🇺🇸Plano, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Woodstock Research Center
🇺🇸Woodstock, Vermont, United States
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
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
START Clinic for Mood and Anxiety Disorders
🇨🇦Toronto, Ontario, Canada
University of Toronto / Centre for Addiction and Mental Health (CAMH)
🇨🇦Toronto, Ontario, Canada
Beijing HuiLongGuan Hospital
🇨🇳Beijing, Changping District, China
Peking University Sixth Hospital
🇨🇳Beijing, Haidian District, China
Hangzhou Seventh People's Hospital
🇨🇳Hangzhou, Hangzhou City, China
Tianjin Anding Hospital
🇨🇳Tianjin, Hexi District, China
The Second Xiangya Hospital of Central South University
🇨🇳Xiangya, Hunan, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
Shanghai Mental Health Center
🇨🇳Shanghai, Minhang District, China
Wuhan Mental Health Center
🇨🇳Wuhan, Qiaokou District, China
The First Affiliated Hospital of Jinan University
🇨🇳Guangzhou, Tianhe District, China
Mental Health Center, West China Hospital, Sichuan University
🇨🇳Chengdu, Wuhou District, China
First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Yuhua District, China
ASST FBF SACCO - Ospedale Universitario Luigi Sacco
🇮🇹Milan, Italy
University School of Medicine of Napoli Federico II
🇮🇹Naples, Italy
University of Pisa
🇮🇹Pisa, Italy
Leiden University Medical Center (LUMC)
🇳🇱Leiden, Netherlands
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Centro de Salud Mental La Corredoria
🇪🇸Oviedo, Spain
University of Turin - university hospital san luigi gonzaga
🇮🇹Turin, Italy
Amsterdam UMC, locatie AMC
🇳🇱Amsterdam, Netherlands
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Centro de Salud San Juan
🇪🇸Salamanca, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain
MAC Clinical Research
🇬🇧Leeds, United Kingdom
Stemax Consult - Healthcare Services Ltd
🇬🇧Stony Stratford, Northamptonshire, United Kingdom
MAC Clinical Research - South Staffordshire
🇬🇧Cannock, South Staffordshire, United Kingdom
MAC Clinical Research-Lancashire
🇬🇧Blackpool, United Kingdom
MAC Clinical Research -- Merseyside
🇬🇧Liverpool, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Bioluminux Ltd
🇬🇧Milton Keynes, United Kingdom
Kingshill Research Centre
🇬🇧Swindon, United Kingdom
MAC Clinical Research-- South Yorkshire
🇬🇧Tankersley, United Kingdom