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

NCT05526391 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: TAK-341-20012022-000336-28jRCT20112200292023-509876-40-00
• Study Type: interventional
• Target: 158
• Locations: 10 countries
• Sites: 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.

Conditions

Multiple System Atrophy

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I Total Score at Week 52

  UMSARS Part I (historical review) is a 12-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 autonomic dysfunction. In this study, the UMSARS was modified to exclude the sexual function item. Thus, total 11 items were assessed. Each item was initially scored on a scale from 0 (normal) to 4 (severe); ratings of normal (0) and mild (1) were then combined and recorded as 0, making minimum score 0 and maximum score 3. The investigator rated the average functional situation for the past 2 weeks according to findings from the participant and caregiver interview and indicated the score that best fit with the participant's status. The total score is a sum of scores from all domains and range from 0 to 33. Higher scores indicate worse impairment.

  Baseline, Week 52

Secondary Outcomes (14)

• Change From Baseline in 11-item UMSARS at Week 52

  Baseline, Week 52

• Change From Baseline in the UMSARS Total Score (UMSARS Part I + Part II) at Week 52

  Baseline, Week 52

• Change From Baseline in UMSARS Part I 11-Item Score at Week 52

  Baseline, Week 52

• Change From Baseline in UMSARS Part II at Week 52

  Baseline, Week 52

• Change From Baseline on Clinical Global Impression-Severity (CGI-S) Score

  Baseline, Week 24 and Week 52

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received TAK-341 matching placebo intravenous (IV) infusions, once every 4 weeks (Q4W) for 52 weeks.

Drug: Placebo

TAK-341

EXPERIMENTAL

Participants received TAK-341, IV Q4W for 52 weeks. An early set of participants initially received 2400 milligrams (mg) to determine pharmacokinetic (PK) parameters. Following the early participants, a dose of 2000 mg was given until the data from the PK participants became available. All participants then received 2400 mg until the end of treatment at 52 weeks.

Drug: TAK-341

Interventions

TAK-341 DRUG

TAK-341 IV infusion

Also known as: MEDI1341

TAK-341

Placebo DRUG

TAK-341-matching placebo IV infusion

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Takeda: lead
• AstraZeneca: collaborator

Study Sites (41)

Quest Research Institute - Alcanza - HyperCore

Farmington Hills, Michigan, 48025, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905-0001, United States

Location

NYU Langone Health

New York, New York, 10016-6402, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27705-4410, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-7208, United States

Location

Inland Northwest Research

Spokane, Washington, 99202-1342, United States

Location

Medizinische Universitat Graz

Graz, Styria, 8036, Austria

Location

Bispebjerg Hospital

København NV, Capital, 2400, Denmark

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

Hopitaux de La Timone

Marseille, Bouches-du-Rhone, 13385, France

Location

Klinikum Groshadern, LMU

München, Bavaria, 81377, Germany

Location

Paracelsus-Elena-Klinik Kassel

Kassel, Hesse, 34128, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

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

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Deutsches Zentrum fur Neurodegenerative Erkrankung

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitatsklinikum Munster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitatsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, 01307, Germany

Location

Universitatsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Charite - Universitatsmedizin Berlin

Berlin, 10117, Germany

Location

IRCCS San Raffaele Roma

Rome, Lazio, 00163, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

Location

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Azienda Ospedale Universita Padova

Padova, Veneto, 35126, Italy

Location

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

Salerno, 84131, Italy

Location

Chiba University Hospital

Chuo-ku, Chiba, 260-8677, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8638, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

The University of Tokyo Hospital

Bunkyo-Ku, Tokyo, 113-0033, Japan

Location

Medical Hospital of Tokyo Medical and Dental University

Bunkyo-Ku, Tokyo, 113-8519, Japan

Location

National Center of Neurology and Psychiatry

Kodaira-Shi, Tokyo, 187-8551, Japan

Location

Campus Neurologico Senior

Loures, Lisbon District, 2674-514, Portugal

Location

Hospital Pedro Hispano

Senhora da Hora, Porto District, 4464-513, Portugal

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Links

• To obtain more information about this study, click this link.

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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 16, 2022
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: June 2, 2026
• Results First Posted: June 2, 2026

Record last verified: 2026-05

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.

Locations

FR (1); IT (6); DE (9); DK (2); GB (1); AU (1); JP (6); PT (2); ES (6); US (7)