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Hope for rare brain disease: new drug trial targets MSA progression

NCT ID NCT06706622

Disease control Sponsor: H. Lundbeck A/S 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This Phase 3 trial tests an experimental drug called amlenetug in 401 people with multiple system atrophy (MSA), a rare and serious brain disorder. The goal is to see if the drug can slow the worsening of symptoms and improve survival. Participants receive either the drug or a placebo, with an option to continue the drug in an open-label extension.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

401 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

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 to 75 years

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.

Key Inclusion Criteria: * The participant has a diagnosis of clinically established multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C), or clinically probable MSA-P or MSA-C, according to the 2022 Movement Disorders Society (MDS) criteria for the diagnosis of MSA at the Screening Visit. * The participant had onset of motor MSA symptoms (that is, parkinsonian and/or cerebellar) within 5 years prior to the Screening Visit in the judgement of the investigator. * The participant has an anticipated survival of \>3 years, in the opinion of the investigator, at the Screening Visit. * The participant has suitable peripheral venous access for investigational medicinal product (IMP) administration and blood sampling. * The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit. Exclusion Criteria: * The participant has previously been dosed with amlenetug. * The participant has taken any active IMP within 3 months or 5 half lives of that product, whichever is longer, prior to the first dose of IMP. * The participant has 2 or more first degree relatives with a history of MSA. * The participant, if of MSA-P subtype, has unexplained anosmia (not explained by other common causes such as allergic rhinitis or smoking, nasal structural lesions, or nasal surgery) on olfactory testing at the Screening Visit. * The participant has evidence (clinically or on magnetic resonance imaging (MRI)) and/or history of any clinically significant disease or condition other than MSA, that is, in the investigator's opinion, likely to affect CNS functioning, e.g., serious neurological disorder, other intracranial or systemic disease. * The participant has a current diagnosis of movement disorders that could mimic MSA, e.g., Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, per investigator discretion. Participants who have previously been incorrectly diagnosed with Parkinson's disease will not be excluded. Other protocol-defined inclusion and exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

multiple system atrophy neurodegenerative disease

As listed by the trial registrant

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

Multiple system atrophy

Contacts and locations

Locations

  • A.O.U. Pisana-Ospedale S. Chiara

    Pisa, 56126, Italy

  • AOU Universita della Campania Luigi Vanvitelli

    Naples, 80138, Italy

  • Baylor College Of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU - Hospital de la Timone

    Marseille, 13385, France

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113, United States

  • Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac

    Montpellier, 34295, France

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

    Lille, 59037, France

  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    Toulouse, 31059, France

  • Chu De La Pitie-Salpetriere

    Paris, 75651, France

  • Cleveland Clinic - Neurological Institute

    Cleveland, Ohio, 44195, United States

  • Clinical Ageing Reseach Unit

    Newcastle upon Tyne, Tyne and Wear, NE4 5LP, United Kingdom

  • Columbia University Medical Center - The Neurological Institute of New York

    New York, New York, 10032-3726, United States

  • Curiositas-ad-Sanum GmbH

    Haag in Oberbayern, 83527, Germany

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192, Japan

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • Gold Coast Hospital

    Southport, Queensland, 4215, Australia

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN)

    Barcelona, 08036, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

    Seville, 41015, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona (Spain), 08041, Spain

  • IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna

    Bologna, 40139, Italy

  • Indiana Health University

    Indianapolis, Indiana, 46202, United States

  • Inland Northwest Research

    Spokane, Washington, 99202, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Keio University Hospital

    Tokyo, 160-8582, Japan

  • Kyung Hee University Hospital

    Seoul, 02447, South Korea

  • Liverpool Hospital - South Western Sydney Local Health District

    Liverpool, New South Wales, 2170, Australia

  • Ludwig-Maximilians-Universitat Munchen Klinikum der Universitat - Grosshadern

    München, 81377, Germany

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Movement Disorders Clinic

    Beelitz-Heilstätten, 14547, Germany

  • NYU Medical Center - Dysautonomia center

    New York, New York, 10016, United States

  • National Center Hospital, National Center of Neurology and Psychiatry

    Kodaira-shi, Tokyo, 187-8551, Japan

  • National Hospital Organization Higashinagoya National Hospital

    Nagoya, Aichi-ken, 465-8620, Japan

  • National Hospital Organization Sendai Nishitaga Hospital

    Sendai, Miyagi, 982-8555, Japan

  • Niigata University Medical And Dental Hospital

    Niigata, 9518520, Japan

  • Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Ho...

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Parkinson's Disease And Movement Disorder Center Of Boca Raton

    Boca Raton, Florida, 33486, United States

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust

    Exeter, EX2 5DW, United Kingdom

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495, Japan

  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Salford, Greater Manchester, M6 8HD, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The National Hospital for Neurology and Neurosurgery

    London, WC1N 3BG, United Kingdom

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • Toronto Western Hospital (TWH)

    Toronto, Ontario, M5T 2S8, Canada

  • Tottori University Hospital

    Yonago-shi, Tottori, 683-8504, Japan

  • Unite d'investigation clinique de Neurologie Rez-de-jardin-Bloc Hopital CHU Pontchaillou

    Rennes, 35033, France

  • Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona

    Salerno, 84100, Italy

  • Universitaetsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...

    Valencia, 46026, Spain

  • University Hospital Tuebingen

    Tübingen, 72076, Germany

  • University Nebraska Medical Center

    Omaha, Nebraska, 68198-8440, United States

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California, San Francisco Neurosciences Clinical Research Unit

    San Francisco, California, 94158, United States

  • University of Florida Norman Fixel Institute for Neurological Diseases

    Gainesville, Florida, 32608, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

  • University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic

    Dallas, Texas, 75390-8565, United States

  • Vanderbilt University Medical Center-Cognitive and Movement Disorders Group

    Nashville, Tennessee, 37232, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Yale New Haven Health

    North Haven, Connecticut, 06473, United States

More trials for these conditions

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