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

NCT ID: NCT04708834

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Troriluzole (BHV-4157)

200 mg daily first 2 weeks, 280 daily following first 2 weeks

Group Type EXPERIMENTAL

Troriluzole (BHV-4157)

Intervention Type DRUG

200 mg daily first 2 weeks, 280 daily following first 2 weeks

Interventions

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Troriluzole (BHV-4157)

200 mg daily first 2 weeks, 280 daily following first 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biohaven Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neurobehavioral Research, Inc

Cedarhurst, New York, United States

Site Status

Bio Behavioral Institute

Great Neck, New York, United States

Site Status

Bioscience Research, LLC

Mount Kisco, New York, United States

Site Status

Hapworth Research

New York, New York, United States

Site Status

New York State Psychiatric Institute

New York, New York, United States

Site Status

Metropolitan Neuro Behavioral Institute

Chandler, Arizona, United States

Site Status

Alea Research

Phoenix, Arizona, United States

Site Status

NoeisisPharma, LLC

Phoenix, Arizona, United States

Site Status

Atria Clinical Research

Little Rock, Arkansas, United States

Site Status

Advanced Research Center, Inc.

Anaheim, California, United States

Site Status

CITrials (Clinical Innovations)

Bellflower, California, United States

Site Status

Southern California Research, LLC

Beverly Hills, California, United States

Site Status

Axiom Research, LLC

Colton, California, United States

Site Status

Global Clinical Trials

Costa Mesa, California, United States

Site Status

ProScience Research Group

Culver City, California, United States

Site Status

WR-PRI, LLC (Encino)

Encino, California, United States

Site Status

Behavioral Research Specialists, LLC

Glendale, California, United States

Site Status

Sun Valley Research Center, Inc.

Imperial, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Synergy Research San Diego

Lemon Grove, California, United States

Site Status

Alliance for Research

Long Beach, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

CalNeuro Research Group

Los Angeles, California, United States

Site Status

Clarity Clinical Research

Los Angeles, California, United States

Site Status

Pharmacology Research Institute (WR-PRI, LLC)

Newport Beach, California, United States

Site Status

Pacific Research Partners

Oakland, California, United States

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North County Clinical Research

Oceanside, California, United States

Site Status

Excell Research, Inc

Oceanside, California, United States

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NRC Research Institute

Orange, California, United States

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Anderson Clinical Research

Redlands, California, United States

Site Status

CI Trials

Riverside, California, United States

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ACRC Studies

San Diego, California, United States

Site Status

Lumos Clinical Research Center, LLC

San Jose, California, United States

Site Status

National Research Institute

Santa Ana, California, United States

Site Status

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Collaborative Neuroscience Research

Torrance, California, United States

Site Status

Pacific Clinical Research Medical Group

Upland, California, United States

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Mountain View Clinical Research

Denver, Colorado, United States

Site Status

Institute of Living / Hartford Hospital

Hartford, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Coastal Connecticut Research, LLC

New London, Connecticut, United States

Site Status

Comprehensive Psychiatric Care

Norwich, Connecticut, United States

Site Status

Topaz Clinical Research

Apopka, Florida, United States

Site Status

Boca Raton Medical Institute

Boca Raton, Florida, United States

Site Status

Advanced Clinical Research Network

Coral Gables, Florida, United States

Site Status

CNS Research of Coral Springs

Coral Springs, Florida, United States

Site Status

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

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University of Florida Department of Psychiatry

Gainesville, Florida, United States

Site Status

Qway Research, LLC

Hialeah, Florida, United States

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Research in Miami Inc

Hialeah, Florida, United States

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Health Care Family Rehab & Research

Hialeah, Florida, United States

Site Status

Galiz Research

Hialeah, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, United States

Site Status

Accel Research Sites (formerly Meridien Research)

Lakeland, Florida, United States

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Innovative Clinical Research, Inc.

Lauderhill, Florida, United States

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Pharmaceutical Research Center, Inc.

Lutz, Florida, United States

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ClinCloud, LLC

Maitland, Florida, United States

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Meridien Research

Maitland, Florida, United States

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Central Miami Medical Institute

Miami, Florida, United States

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Clintex Research

Miami, Florida, United States

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Sanchez Clinical Research Inc

Miami, Florida, United States

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Med-Care Research

Miami, Florida, United States

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FIRC

Miami, Florida, United States

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Florida Research Center, Inc.

Miami, Florida, United States

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Ezy Medical Research, Co.

Miami, Florida, United States

Site Status

Miami Dade Medical Research Institute

Miami, Florida, United States

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Pro-Care Research Center

Miami Gardens, Florida, United States

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South Florida Research Phase I-IV, Inc.

Miami Springs, Florida, United States

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Advanced Research for Health Improvement

Naples, Florida, United States

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Bayside Clinical Research, LLC

New Port Richey, Florida, United States

Site Status

Bravo Health Care Center

North Bay Village, Florida, United States

Site Status

Behavioral Clinical Research

North Miami, Florida, United States

Site Status

Harmony Clinical Research

North Miami Beach, Florida, United States

Site Status

Medical Research Group of Central Florida

Orange City, Florida, United States

Site Status

APG Research, LLC

Orlando, Florida, United States

Site Status

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

Site Status

Omega Research Consultants

Orlando, Florida, United States

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IMIC Inc

Palmetto Bay, Florida, United States

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MedBio Trials

Pembroke Pines, Florida, United States

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DMI Research

Pinellas Park, Florida, United States

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Lenus Research & Medical Group, LLC

Sweetwater, Florida, United States

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Stedman Clinical Trials

Tampa, Florida, United States

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Olympian Clinical Research

Tampa, Florida, United States

Site Status

Conquest Research LLC

Winter Park, Florida, United States

Site Status

NeuroTrials Research Inc

Atlanta, Georgia, United States

Site Status

iResearch Atlanta, LLC

Decatur, Georgia, United States

Site Status

iResearch Savannah

Savannah, Georgia, United States

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Renew Health Clinical Research, LLC

Snellville, Georgia, United States

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Northwest Clinical Trials

Boise, Idaho, United States

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Uptown Research Institute

Chicago, Illinois, United States

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University of Chicago Department of Psychiatry & Behavioral Neuroscience

Chicago, Illinois, United States

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Revive Research Institute

Elgin, Illinois, United States

Site Status

Capstone Clinical Research

Libertyville, Illinois, United States

Site Status

AMR-Baber Research, Inc

Naperville, Illinois, United States

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Collective Medical Research

Prairie Village, Kansas, United States

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Northern Light Acadia Hospital

Bangor, Maine, United States

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CBH Health

Gaithersburg, Maryland, United States

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Pharmasite Research, Inc.

Pikesville, Maryland, United States

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Continental Clinical Solutions, LLC

Towson, Maryland, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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Boston Clinical Trials

Boston, Massachusetts, United States

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ActivMed Practices and Research

Methuen, Massachusetts, United States

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Sisu at RMG

Springfield, Massachusetts, United States

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Adams Clinical

Watertown, Massachusetts, United States

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Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

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Precise Research Centers

Flowood, Mississippi, United States

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Psychiatric Care and Research Center

O'Fallon, Missouri, United States

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PsychCare Consultants Research

St Louis, Missouri, United States

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Boeson Research

Missoula, Montana, United States

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Altea Research

Las Vegas, Nevada, United States

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Hassman Research Institute

Berlin, New Jersey, United States

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Center for Emotional Fitness

Cherry Hill, New Jersey, United States

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Bio Behavioral Health

Toms River, New Jersey, United States

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Integrative Clinical Trials, LLC

Brooklyn, New York, United States

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SPRI Clinical Trials, LLC

Brooklyn, New York, United States

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Manhattan Behavioral Medicine, PLLC

New York, New York, United States

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Finger Lakes Clinical Research

Rochester, New York, United States

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Richmond Behavioral Associates

Staten Island, New York, United States

Site Status

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

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Clinical Inquest Center, Ltd

Beavercreek, Ohio, United States

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NeuroScience Research Center, LLC.

Canton, Ohio, United States

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CTI Clinical Research Center

Cincinnati, Ohio, United States

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Midwest Clinical Research Center

Dayton, Ohio, United States

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IPS Research

Oklahoma City, Oklahoma, United States

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Central States Research, LLC

Tulsa, Oklahoma, United States

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Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

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Suburban Research Associates

Media, Pennsylvania, United States

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

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Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

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BioBehavioral Research of Austin

Austin, Texas, United States

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Inquest Clinical Research

Baytown, Texas, United States

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DiscoveResearch, Inc. (DRI)

Bryan, Texas, United States

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FutureSearch Trials of Dallas, LP

Dallas, Texas, United States

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Relaro Medical Trials

Dallas, Texas, United States

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InSite Clinical Research

DeSoto, Texas, United States

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North Texas Clinical Trials

Fort Worth, Texas, United States

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Baylor College of Medicine

Houston, Texas, United States

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Clinical Trial Network

Houston, Texas, United States

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Texas Center for Drug Development, Inc.

Houston, Texas, United States

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SMS Clinical Research

Mesquite, Texas, United States

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Mt.Olympus Medical Research LLC

Missouri City, Texas, United States

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AIM Trials

Plano, Texas, United States

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Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

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Grayline Research Center

Wichita Falls, Texas, United States

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Woodstock Research Center

Woodstock, Vermont, United States

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Northwest Clinical Research Center

Bellevue, Washington, United States

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University of Calgary

Calgary, Alberta, Canada

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Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, Canada

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McMaster University, Hamilton Health Sciences

Hamilton, Ontario, Canada

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Queen's University

Kingston, Ontario, Canada

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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START Clinic for Mood and Anxiety Disorders

Toronto, Ontario, Canada

Site Status

University of Toronto / Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Site Status

Institute of Neuroscience, University of Firenze

Florence, , Italy

Site Status

ASST FBF SACCO - Ospedale Universitario Luigi Sacco

Milan, , Italy

Site Status

University School of Medicine of Napoli Federico II

Naples, , Italy

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University of Pisa

Pisa, , Italy

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University of Turin - university hospital san luigi gonzaga

Turin, , Italy

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Amsterdam UMC, locatie AMC

Amsterdam, , Netherlands

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Leiden University Medical Center (LUMC)

Leiden, , Netherlands

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Hospital Universitario de Bellvitge

Barcelona, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Centro de Salud Mental La Corredoria

Oviedo, , Spain

Site Status

Centro de Salud San Juan

Salamanca, , Spain

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Hospital Álvaro Cunqueiro

Vigo, , Spain

Site Status

MAC Clinical Research-Lancashire

Blackpool, , United Kingdom

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Surrey and Borders Partnership NHS Foundation Trust

Chertsey, , United Kingdom

Site Status

MAC Clinical Research -- Merseyside

Liverpool, , United Kingdom

Site Status

South West London and St George's Mental Health NHS Trust Springfield University Hospital

London, , United Kingdom

Site Status

MAC Clinical Research-Greater Manchester

Manchester, , United Kingdom

Site Status

Greater Manchester Mental Health NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Bioluminux Ltd

Milton Keynes, , United Kingdom

Site Status

MAC Clinical Research-- South Yorkshire

Tankersley, , United Kingdom

Site Status

Countries

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United States Canada Italy Netherlands Spain United Kingdom

Other Identifiers

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BHV4157-209

Identifier Type: -

Identifier Source: org_study_id

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