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

Last updated: July 31, 2024
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

2

Condition

Multiple System Atrophy

Treatment

Placebo

TAK-341

Clinical Study ID

NCT05526391
TAK-341-2001
2022-000336-28
jRCT2011220029
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

Diagnostic:

  1. The participant has a diagnosis of possible or probable MSA using the modifiedGilman et al, 2008 diagnostic criteria.

  2. The participant's onset of first MSA symptoms occurred ≤4 years before screening, asassessed by the investigator.

  3. Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale.

Exclusion

Exclusion criteria:

Medical History:

  1. The participant has any contraindication to study procedures.

Diagnostic Assessments:

  1. Presence of confounding diagnosis and/or conditions that could affect participant'ssafety 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 ofthe data from the present study, per consultation with medical monitor or designee.

Other:

  1. The participant has participated in another study investigating active or passiveimmunization against α-synuclein (αSYN) for progressive disease (PD) or MSA, or hashad immunoglobulin G therapy, within 6 months before screening.

Study Design

Total Participants: 159
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 09, 2022
Estimated Completion Date:
July 30, 2025

Study Description

The drug being tested in this study is called TAK-341. The study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of intravenous (IV) TAK-341 in participants with multiple system atrophy (MSA).

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.

Connect with a study center

  • Medizinische Universitat Graz

    Graz, Steiermark 8036
    Austria

    Site Not Available

  • Medizinische Universitat Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Bispebjerg Hospital

    Kobenhavn NV, Capital 2400
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Hopitaux de La Timone

    Marseille, Bouches-du-Rhone 13385
    France

    Site Not Available

  • Hopital Purpan

    Toulouse, Haute-Garonne 31000
    France

    Site Not Available

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67098
    France

    Site Not Available

  • Universitatsklinikum Tubingen

    Tubingen, Baden-Wurttemberg 72076
    Germany

    Site Not Available

  • Universitatsklinikum Ulm

    Ulm, Baden-Wurttemberg 89081
    Germany

    Site Not Available

  • Klinikum Groshadern, LMU

    Munchen, Bayern 81377
    Germany

    Site Not Available

  • Paracelsus-Elena-Klinik Kassel

    Kassel, Hessen 34128
    Germany

    Site Not Available

  • Universitatsklinikum Giesen und Marburg GmbH

    Marburg, Hessen 35043
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) - St. Josef-Hospital

    Bochum, Nordrhein-Westfalen 44791
    Germany

    Site Not Available

  • Deutsches Zentrum fur Neurodegenerative Erkrankung

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Universitatsklinikum Munster

    Munster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Ospedale Bellaria

    Bologna, Emilia-Romagna 40139
    Italy

    Site Not Available

  • IRCCS San Raffaele Roma

    Roma, Lazio 00163
    Italy

    Site Not Available

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Lombardia 20089
    Italy

    Site Not Available

  • Azienda Ospedale Universita Padova

    Padova, Veneto 35126
    Italy

    Site Not Available

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi dAragona

    Salerno, 84131
    Italy

    Site Not Available

  • Hokkaido University Hospital

    Sapporo-Shi, Hokkaido 060-8638
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto-Shi, Kyoto 606-8507
    Japan

    Site Not Available

  • Chiba University Hospital

    Chuo-ku, Tiba 260-8677
    Japan

    Site Not Available

  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo-Ku, Tokyo 113-8519
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Bunkyo-Ku, Tokyo 113-0033
    Japan

    Site Not Available

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo 187-8551
    Japan

    Site Not Available

  • Campus Neurologico Senior

    Loures, Lisboa 2674-514
    Portugal

    Site Not Available

  • Hospital Pedro Hispano

    Senhora Da Hora, Porto 4464-513
    Portugal

    Site Not Available

  • Hospital de Santa Maria-Avenida Prof. Egas Moniz

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya 48903
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Southampton General Hospital

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Newcastle University

    Newcastle Upon Tyne, Tyne And Wear NE4 5PL
    United Kingdom

    Site Not Available

  • The National Hospital for Neurology and Neurosurgery

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • UAMS Health - Movement Disorders Clinic

    Little Rock, Arkansas 72205-7101
    United States

    Site Not Available

  • UCLA Neurological Services

    Los Angeles, California 90095-8346
    United States

    Site Not Available

  • AdventHealth Innovation Tower

    Orlando, Florida 32803-1248
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center - 330 Brookline Ave

    Boston, Massachusetts 02215-5324
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114-2621
    United States

    Site Not Available

  • Quest Research Institute - Alcanza - HyperCore

    Farmington Hills, Michigan 48025
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905-0001
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016-6402
    United States

    Site Not Available

  • Duke University School of Medicine

    Durham, North Carolina 27705-4410
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390-7208
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030-4202
    United States

    Site Not Available

  • Inland Northwest Research

    Spokane, Washington 99202-1342
    United States

    Site Not Available

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