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A Study of TAK-341 in Treatment of Multiple System Atrophy
Sponsor: Takeda
Summary
The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS). The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. This trial will be conducted in North America, Europe and Asia.
Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-341 in Subjects With Multiple System Atrophy
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2022-11-16
Completion Date
2025-07-28
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Placebo
TAK-341-matching placebo IV infusion
TAK-341
TAK-341 IV infusion
Locations (41)
Quest Research Institute - Alcanza - HyperCore
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Health
New York, New York, United States
Duke University School of Medicine
Durham, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Inland Northwest Research
Spokane, Washington, United States
Medizinische Universitat Graz
Graz, Styria, Austria
Bispebjerg Hospital
København NV, Capital, Denmark
Aarhus Universitetshospital
Aarhus N, Denmark
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, France
Klinikum Groshadern, LMU
München, Bavaria, Germany
Paracelsus-Elena-Klinik Kassel
Kassel, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
Bochum, North Rhine-Westphalia, Germany
Deutsches Zentrum fur Neurodegenerative Erkrankung
Bonn, North Rhine-Westphalia, Germany
Universitatsklinikum Munster
Münster, North Rhine-Westphalia, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Charite - Universitatsmedizin Berlin
Berlin, Germany
IRCCS San Raffaele Roma
Rome, Lazio, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Azienda Ospedale Universita Padova
Padova, Veneto, Italy
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi dAragona
Salerno, Italy
Chiba University Hospital
Chuo-ku, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
The University of Tokyo Hospital
Bunkyo-Ku, Tokyo, Japan
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-Ku, Tokyo, Japan
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, Japan
Campus Neurologico Senior
Loures, Lisbon District, Portugal
Hospital Pedro Hispano
Senhora da Hora, Porto District, Portugal
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Southampton General Hospital
Southampton, Hampshire, United Kingdom