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Hope for rare brain disease: new drug aims to slow MSA

NCT ID NCT05104476

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an experimental drug called Lu AF82422 in 64 people with multiple system atrophy (MSA), a rare and serious brain disease. The goal is to see if the drug can slow down the worsening of symptoms like movement problems and daily living difficulties. Participants receive either the drug or a placebo, and the study measures changes over time using a standard rating scale.

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

64 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Mar 2028

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 is diagnosed with possible or probable MSA of the multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C) sub-type at the Screening Visit. * The participant had onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator. * The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit. * The participant has a cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score ≥22 at the Screening Visit. Open-label Extension Entry Criteria * The participant has completed the EoT Visit and did not withdraw in the DBP. * The participant has consented to participate in the OLE. * The participant has completed the DBP within the last 5 months and will be enrolled into the OLE no later than end of Q1 2024. * The participant is, in the Investigator's opinion, likely to comply with the protocol. * The participant has not received any other Investigational product since the EOoTDBP Visit. Key Exclusion Criteria: * The participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months. * The participant has any past or current treatment with an active vaccine targeting α-synuclein. * The participant has 2 or more blood relatives with a history of MSA. * The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease). * The participant has a current diagnosis of movement disorders that could mimic MSA (for example, Parkinson' 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. Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

multiple system atrophy neurodegenerative disease pure autonomic failure

As listed by the trial registrant

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

Multiple system atrophy

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113, United States

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

    New York, New York, 10032, United States

  • Endeavor Health - Glenbrook Hospital

    Glenview, Illinois, 60026, United States

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192, Japan

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • NYU Langone Health Medical Center

    New York, New York, 10016, United States

  • National Hospital Organization Sendai Nishitaga Hospital

    Sendai, Miyagi, 982-8555, Japan

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

    Boca Raton, Florida, 33486, United States

  • Penn State Milton S. Hershey Medical Center - Penn State Hershey Neuroscience Institute (PSHNI)

    Hershey, Pennsylvania, 17033, United States

  • Rush University Medical Center, Rush University Cancer Center

    Chicago, Illinois, 60612, United States

  • The Parkinsons and Movement Disorder Institute

    Fountain Valley, California, 92708, United States

  • University Nebraska Medical Center

    Omaha, Nebraska, 68198-8440, United States

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of California - San Diego

    La Jolla, California, 92037, 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

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