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New drug TAK-341 tested in rare brain disease trial

NCT ID NCT05526391

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested whether TAK-341, given as an IV infusion every 4 weeks for a year, can slow the progression of multiple system atrophy (MSA), a rare and serious brain disorder. The study enrolled 158 adults with MSA across North America, Europe, and Asia. Researchers measured changes in symptoms like movement and autonomic function using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-341 (a monoclonal antibody given by IV infusion)
What this could lead to
If it works, this could point toward a treatment that slows progression of multiple system atrophy, a rare and devastating neurological disease.
What could go wrong
This is a mid-stage trial with only 158 participants, so results may not apply to everyone. The drug may not show meaningful benefit over placebo, and IV infusions carry risks like infusion reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

158 people

The number who actually took part.

Started

Nov 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Diagnostic: 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: 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'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.

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Conditions

The condition(s) this trial relates to.

multiple system atrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple system atrophy

Contacts and locations

Locations

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Azienda Ospedale Universita Padova

    Padova, Veneto, 35126, Italy

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

    Salerno, 84131, Italy

  • Bispebjerg Hospital

    København NV, Capital, 2400, Denmark

  • Campus Neurologico Senior

    Loures, Lisbon District, 2674-514, Portugal

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117, Germany

  • Chiba University Hospital

    Chuo-ku, Chiba, 260-8677, Japan

  • Deutsches Zentrum fur Neurodegenerative Erkrankung

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Duke University School of Medicine

    Durham, North Carolina, 27705-4410, United States

  • 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

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8638, Japan

  • Hopitaux de La Timone

    Marseille, Bouches-du-Rhone, 13385, France

  • Hospital Pedro Hispano

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

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • IRCCS San Raffaele Roma

    Rome, Lazio, 00163, Italy

  • Inland Northwest Research

    Spokane, Washington, 99202-1342, United States

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089, Italy

  • Klinikum Groshadern, LMU

    München, Bavaria, 81377, Germany

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507, Japan

  • Mayo Clinic

    Rochester, Minnesota, 55905-0001, United States

  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo-Ku, Tokyo, 113-8519, Japan

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Medizinische Universitat Graz

    Graz, Styria, 8036, Austria

  • NYU Langone Health

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

  • National Center of Neurology and Psychiatry

    Kodaira-Shi, Tokyo, 187-8551, Japan

  • Paracelsus-Elena-Klinik Kassel

    Kassel, Hesse, 34128, Germany

  • Quest Research Institute - Alcanza - HyperCore

    Farmington Hills, Michigan, 48025, United States

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The University of Tokyo Hospital

    Bunkyo-Ku, Tokyo, 113-0033, Japan

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

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Universitatsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Saxony, 01307, Germany

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Universitatsklinikum Munster

    Münster, North Rhine-Westphalia, 48149, Germany

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-7208, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.