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A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Summary
The primary objective of the study is to evaluate the efficacy of TEV-56286 administered orally for the treatment of adult participants with Multiple System Atrophy (MSA). A secondary objective of the study is to evaluate specific efficacy parameters of TEV-56286. Another secondary objective is to evaluate the safety and tolerability of TEV-56286. The planned study period per participant is 56 weeks including a screening period (up to 4 weeks), a 48-week double-blind treatment period, and a follow-up visit (approximately 4 weeks after the end of the double-blind treatment period). The study duration will be approximately 27 months.
Official title: A Multi-centered, Double-blind, Randomized, Placebo-controlled, Parallel Group Phase 2 Study of TEV-56286 for the Treatment of Patients With Multiple System Atrophy (TOPAS-MSA)
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
349
Start Date
2024-10-02
Completion Date
2027-09-15
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
TEV-56286
TEV-56286 capsules administered orally
Placebo
Matching placebo administered orally
Locations (68)
University of California - San Diego
La Jolla, California, United States
Teva Investigational Site 15545
Los Angeles, California, United States
University California Los Angeles Medical Center (Ucla)
Los Angeles, California, United States
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, United States
Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton, Florida, United States
Teva Investigational Site 15544
Boca Raton, Florida, United States
University of South Florida Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Rush University Medical Center-Allergy/ Immunology Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Detroit Clinical Research Center, PC
Farmington Hills, Michigan, United States
Teva Investigational Site 15870
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Medical Center - Dysautonomia center
New York, New York, United States
Columbia University Medical Center - The Neurological Institute of New York
New York, New York, United States
Duke University School of Medicine - Duke Neurological Disorders Clinic - Morreene Road Location
Durham, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Teva Investigational Site 15735
Hershey, Pennsylvania, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, United States
Teva Investigational Site 15869
Georgetown, Texas, United States
Texas Movement Disorder Specialists
Georgetown, Texas, United States
Integrated Neurology Services
Alexandria, Virginia, United States
Teva Investigational Site 15873
Alexandria, Virginia, United States
Inland Northwest Research
Spokane, Washington, United States
Teva Investigational Site 15543
Spokane, Washington, United States
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, France
CHU de Caen
Caen, France
CHU - Hospital de la Timone
Marseille, France
Chu De La Pitie-Salpetriere
Paris, France
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, France
Kliniken Beelitz GmbH - Neurologisches Fachkrankenhaus fuer Bewegungsstoerungen / Parkinson
Beelitz, Germany
Universitatsklinikum Carl Gustav Carus an der Technischen Universitat Dresden
Dresden, Germany
University Hospital Duesseldorf
Düsseldorf, Germany
Paracelsus-Elena-Klinik
Kassel, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Universitatsklinikum Giessen und Marburg GmbH
Marburg, Germany
LMU - Klinikum der Universitaet Muenchen - Campus Grosshadern
München, Germany
Universitaetsklinikum Muenster
Münster, Germany
University Of Ulm
Ulm, Germany
Rambam Health Care Campus (RHCC)
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
Bologna, Italy
Clinica Neurologica-Aou Policlinico-Vittorio Emanuele-Po G. Rodolico
Catania, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario Sa
Milan, Italy
Azienda Ospedale Universita Padova
Padova, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
Roma, Italy
Universita degli Studi di Salerno - Facolta di Medicina e Chirurgia
Salerno, Italy
Chiba University Hospital
Chiba, Japan
Tokyo Metropolitan Neurological Hospital
Fuchū, Japan
Gifu University Hospital
Gifu, Japan
Niigata University Medical & Dental Hospital
Niigata, Japan
National Hospital Organization Sagamihara Hospital
Sagamihara, Japan
Hyogo-Chuo National Hospital
Sanda-shi, Japan
National Hospital Organization Sendai Nishitaga Hospital
Sendai, Japan
Klinicki Centar Srbije (University Clinical Center of Serbia - KCS)
Belgrade, Serbia
Hospital Universitario Cruces
Barakaldo, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Pamplona, Spain
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain