A Study of TAK-341 in Treatment of Multiple System Atrophy
NCT ID: NCT05526391
Last Updated: 2025-08-24
Study Results
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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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2022-11-09
2025-07-28
Brief Summary
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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.
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Detailed Description
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The study will enroll approximately 138 participants. The study comprises a screening period of up to 42 days (6 weeks), a 52-week double-blind treatment period, and a follow-up safety visit. Participants will be randomly assigned (by chance, like flipping a coin) to one of the treatment schedules-which will remain undisclosed to the participant, care provider and investigator during the study:
* Early PK Cohort: TAK-341
* Early PK Cohort: Placebo
* Main Cohort: TAK-341
* Main Cohort: Placebo
The change from baseline in UMSARS will be measured at Week 52 post-dose.
This multi-center trial will be conducted worldwide. The duration of treatment in this study will be 52 weeks. Participants will make a follow-up visit to the site after approximately 90 days after the last dose of study treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Early PK Cohort: TAK-341
Participants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks.
TAK-341
TAK-341 IV infusion
Early PK Cohort: Placebo
Participants will be randomized to receive placebo at 4-week intervals for up to 52 weeks.
Placebo
TAK-341 placebo-matching IV infusion
Main Cohort: TAK-341
Participants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks.
TAK-341
TAK-341 IV infusion
Main Cohort: Placebo
Participants will be randomized to receive placebo at 4-week intervals for up to 52 weeks.
Placebo
TAK-341 placebo-matching IV infusion
Interventions
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TAK-341
TAK-341 IV infusion
Placebo
TAK-341 placebo-matching IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.
2. The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator.
3. Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale.
Exclusion Criteria
1\. The participant has any contraindication to study procedures.
Diagnostic Assessments:
1. Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement.
2. The participant's participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee.
Other:
1\. The participant has participated in another study investigating active or passive immunization against α-synuclein (αSYN) for progressive disease (PD) or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Padua, 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
Countries
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Related Links
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To obtain more information about this study, click this link.
Other Identifiers
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2022-000336-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2011220029
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-509876-40-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-341-2001
Identifier Type: -
Identifier Source: org_study_id
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