A Study of TAK-341 in Treatment of Multiple System Atrophy

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple System Atrophy

In brief

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.

Key facts

Study ID

NCT05526391

Run by

Takeda

People needed

158

Starts

2022-11-16

Expected to finish

2025-07-28

Last updated by the study team

2026-06-02

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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