A Study of TAK-341 in Treatment of Multiple System Atrophy
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
4 other identifiers
interventional
159
10 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2022
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedStudy Start
First participant enrolled
November 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2025
CompletedAugust 24, 2025
August 1, 2025
2.7 years
September 1, 2022
August 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in a Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I at Week 52
UMSARS Part I (historical review) is a 11-item scale that was adapted from the Unified Parkinson's Disease Rating Scale (UPDRS) and is used to assess activities related to motor disability and related to autonomic dysfunction. Each item is scored from 0 (normal) to 3 (severe). The total score is a sum of scores from all domains and can range from 0 to 33. Higher scores mean poorer health.
Up to 52 weeks
Secondary Outcomes (14)
Change From Baseline in 11-item UMSARS at Week 52
Up to 52 weeks
Change From Baseline in UMSARS Total Score (UMSARS Part I + Part II) at Week 52
Up to 52 weeks
Change From Baseline in UMSARS Part I at Week 52
Up to 52 weeks
Change From Baseline in UMSARS Part II at Week 52
Up to 52 weeks
Clinical Global Impression-Severity (CGI-S) Score
Up to 52 weeks
- +9 more secondary outcomes
Study Arms (4)
Early PK Cohort: TAK-341
EXPERIMENTALParticipants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks.
Early PK Cohort: Placebo
PLACEBO COMPARATORParticipants will be randomized to receive placebo at 4-week intervals for up to 52 weeks.
Main Cohort: TAK-341
EXPERIMENTALParticipants will be randomized to receive TAK-341 at 4-week intervals for up to 52 weeks.
Main Cohort: Placebo
PLACEBO COMPARATORParticipants will be randomized to receive placebo at 4-week intervals for up to 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnostic:
- The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.
- The participant's onset of first MSA symptoms occurred ≤4 years before screening, as assessed by the investigator.
- Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale.
You may not qualify if:
- Medical History:
- \. The participant has any contraindication to study procedures.
- Diagnostic Assessments:
- Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement.
- 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:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- AstraZenecacollaborator
Study Sites (41)
Quest Research Institute - Alcanza - HyperCore
Farmington Hills, Michigan, 48025, United States
Mayo Clinic
Rochester, Minnesota, 55905-0001, United States
NYU Langone Health
New York, New York, 10016-6402, United States
Duke University School of Medicine
Durham, North Carolina, 27705-4410, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-7208, United States
Inland Northwest Research
Spokane, Washington, 99202-1342, United States
Medizinische Universitat Graz
Graz, Styria, 8036, Austria
Bispebjerg Hospital
København NV, Capital, 2400, Denmark
Aarhus Universitetshospital
Aarhus N, 8200, Denmark
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, 13385, France
Klinikum Groshadern, LMU
München, Bavaria, 81377, Germany
Paracelsus-Elena-Klinik Kassel
Kassel, Hesse, 34128, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital
Bochum, North Rhine-Westphalia, 44791, Germany
Deutsches Zentrum fur Neurodegenerative Erkrankung
Bonn, North Rhine-Westphalia, 53127, Germany
Universitatsklinikum Munster
Münster, North Rhine-Westphalia, 48149, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, 01307, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Charite - Universitatsmedizin Berlin
Berlin, 10117, Germany
IRCCS San Raffaele Roma
Rome, Lazio, 00163, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta
Milan, Lombardy, 20133, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089, Italy
Azienda Ospedale Universita Padova
Padua, Veneto, 35126, Italy
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi dAragona
Salerno, 84131, Italy
Chiba University Hospital
Chuo-ku, Chiba, 260-8677, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8638, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
The University of Tokyo Hospital
Bunkyo-Ku, Tokyo, 113-0033, Japan
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-Ku, Tokyo, 113-8519, Japan
National Center of Neurology and Psychiatry
Kodaira-Shi, Tokyo, 187-8551, Japan
Campus Neurologico Senior
Loures, Lisbon District, 2674-514, Portugal
Hospital Pedro Hispano
Senhora da Hora, Porto District, 4464-513, Portugal
Hospital Universitario Cruces
Barakaldo, Vizcaya, 48903, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2022
First Posted
September 2, 2022
Study Start
November 9, 2022
Primary Completion
July 28, 2025
Study Completion
July 28, 2025
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.