A Trial of Lu AF82422 in Participants With Multiple System Atrophy (MSA)

Last updated: October 14, 2025
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Neurologic Disorders

Multiple System Atrophy

Multiple Sclerosis

Treatment

Placebo

Lu AF82422

Clinical Study ID

NCT06706622
20432A
2024-517169-18-00
  • Ages 40-75
  • All Genders

Study Summary

The main goal of this trial is to evaluate the efficacy and safety of Lu AF82422 for the treatment of participants with Multiple System Atrophy (MSA).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • The participant has a diagnosis of clinically established multiple system atrophyparkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C), orclinically 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 (i.e., parkinsonian and/orcerebellar) within 5 years prior to the Screening Visit in the judgement of theinvestigator.

  • The participant has an anticipated survival of >3 years, in the opinion of theinvestigator, at the Screening Visit.

  • The participant has suitable peripheral venous access for investigational medicinalproduct (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

Exclusion Criteria:

  • The participant has previously been dosed with Lu AF82422.

  • The participant has taken any IMP <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 byother 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' disease, dementia with Lewy bodies, essential tremor, progressivesupranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasaldegeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, perinvestigator discretion. Participants who have previously been incorrectly diagnosedwith Parkinson's disease will not be excluded.

Other protocol-defined inclusion and exclusion criteria apply.

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 03, 2024
Estimated Completion Date:
October 25, 2029

Study Description

This study will consist of a 3-6-week screening period, a 72-week placebo-controlled period (PCP), and will include a 72-week optional dose-blinded open-label treatment extension (OLE) period. Participants in the PCP will be randomized to Lu AF82422 high dose, Lu AF82422 low dose or placebo (1:1:1). All participants entering the OLE will receive Lu AF82422 during the OLE. Participants will receive intravenous infusions approximately every 4 weeks during both the PCP and OLE.

Connect with a study center

  • Liverpool Hospital - South Western Sydney Local Health District

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Liverpool Hospital - South Western Sydney Local Health District

    Liverpool 2159851, New South Wales 2155400 2170
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead 2143973, New South Wales 2155400 2145
    Australia

    Active - Recruiting

  • Gold Coast Hospital

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Gold Coast Hospital

    Southport 2148928, Queensland 2152274 4215
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Active - Recruiting

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

    Bordeaux, 33076
    France

    Site Not Available

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

    Bordeaux 3031582, 33076
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

    Lille, 59037
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

    Lille 2998324, 59037
    France

    Active - Recruiting

  • CHU - Hospital de la Timone

    Marseille 2995469, 13385
    France

    Active - Recruiting

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

    Montpellier, 34295
    France

    Site Not Available

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

    Montpellier 2992166, 34295
    France

    Active - Recruiting

  • Chu De La Pitie-Salpetriere

    Paris, 75651
    France

    Site Not Available

  • Chu De La Pitie-Salpetriere

    Paris 2988507, 75651
    France

    Active - Recruiting

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

    Rennes 2983990, 35033
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    Toulouse, 31059
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    Toulouse 2972315, 31059
    France

    Active - Recruiting

  • Movement Disorders Clinic

    Beelitz-Heilstatten, 14547
    Germany

    Site Not Available

  • Movement Disorders Clinic

    Beelitz-Heilstätten 2951592, 14547
    Germany

    Active - Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, 91054
    Germany

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  • Universitaetsklinikum Erlangen

    Erlangen 2929567, 91054
    Germany

    Active - Recruiting

  • Curiositas-ad-sanum Beratungs-und Studien GmbH

    Haag in Oberbayern, 83527
    Germany

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  • Curiositas-ad-sanum Beratungs-und Studien GmbH

    Haag in Oberbayern 2913210, 83527
    Germany

    Active - Recruiting

  • University Hospital Tuebingen

    Tuebingen, 72076
    Germany

    Site Not Available

  • University Hospital Tuebingen

    Tübingen 2820860, 72076
    Germany

    Active - Recruiting

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

    Bologna, 40139
    Italy

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

    Bologna 3181928, 40139
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, 20122
    Italy

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  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan 3173435, 20122
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan 3173435, 20133
    Italy

    Active - Recruiting

  • AOU Universita della Campania Luigi Vanvitelli

    Napoli 9031661, 80138
    Italy

    Active - Recruiting

  • A.O.U. Pisana-Ospedale S. Chiara

    Pisa, 56126
    Italy

    Site Not Available

  • A.O.U. Pisana-Ospedale S. Chiara

    Pisa 3170647, 56126
    Italy

    Active - Recruiting

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

    Salerno, 84100
    Italy

    Site Not Available

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

    Salerno 3168673, 84100
    Italy

    Active - Recruiting

  • Fujita Health University Hospital

    Toyoake 6822210, Aichi-ken 1865694 470-1192
    Japan

    Active - Recruiting

  • Gifu University Hospital

    Gifu City, Gifu 501-1194
    Japan

    Site Not Available

  • Gifu University Hospital

    Gifu 1863641, Gifu 1863640 501-1194
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo 2128295, Hokkaido 2130037 060-8648
    Japan

    Active - Recruiting

  • National Hospital Organization Sendai Nishitaga Hospital

    Sendai, Miyagi 982-8555
    Japan

    Site Not Available

  • National Hospital Organization Sendai Nishitaga Hospital

    Sendai 2111149, Miyagi 2111888 982-8555
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 1850144 113-8431
    Japan

    Active - Recruiting

  • National Center Hospital, National Center of Neurology and Psychiatry

    Kodaira-shi, Tokyo 1850144 187-8551
    Japan

    Active - Recruiting

  • Tottori University Hospital

    Yonago-shi, Tottori 1849890 683-8504
    Japan

    Active - Recruiting

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495
    Japan

    Active - Recruiting

  • Niigata University Medical And Dental Hospital

    Niigata, 9518520
    Japan

    Site Not Available

  • Niigata University Medical And Dental Hospital

    Niigata 1855431, 9518520
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo, 160-8582
    Japan

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  • Keio University Hospital

    Tokyo 1850147, 160-8582
    Japan

    Active - Recruiting

  • Kyung Hee University Hospital

    Seoul, 02447
    Korea, Republic of

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  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital

    Seoul 1835848, 02447
    South Korea

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  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

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  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

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

    Barcelona, 08036
    Spain

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  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

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

    Barcelona 3128760, 08036
    Spain

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  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

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  • Hospital de la Santa Creu i Sant Pau

    Barcelona (Spain), 08041
    Spain

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  • Hospital de la Santa Creu i Sant Pau

    Barcelona (Spain) 3128760, 08041
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

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  • Hospital Universitario de La Princesa

    Madrid 3117735, 28006
    Spain

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

    Sevilla, 41015
    Spain

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    Seville 2510911, 41015
    Spain

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

    Valencia, 46026
    Spain

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

    Valencia 2509954, 46026
    Spain

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  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Salford, Greater Manchester M6 8HD
    United Kingdom

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  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Salford 2638671, Greater Manchester M6 8HD
    United Kingdom

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

    Oxford 2640729, Oxfordshire OX3 9DU
    United Kingdom

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  • Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde

    Glasgow, Scotland G51 4TF
    United Kingdom

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  • Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hosp...

    Glasgow, Scotland G51 4TF
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde

    Glasgow 2648579, Scotland 2638360 G51 4TF
    United Kingdom

    Active - Recruiting

  • Clinical Ageing Reseach Unit

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

    Site Not Available

  • Clinical Ageing Reseach Unit

    Newcastle upon Tyne 2641673, Tyne and Wear NE4 5LP
    United Kingdom

    Active - Recruiting

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

    Exeter 2649808, EX2 5DW
    United Kingdom

    Active - Recruiting

  • The National Hospital for Neurology and Neurosurgery

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • The National Hospital for Neurology and Neurosurgery

    London 2643743, WC1N 3BG
    United Kingdom

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  • Mayo Clinic

    Scottsdale, Arizona 85259
    United States

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  • Mayo Clinic

    Scottsdale 5313457, Arizona 5551752 85259
    United States

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  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

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  • University of Arkansas for Medical Sciences

    Little Rock 4119403, Arkansas 4099753 72205
    United States

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  • University of California, San Francisco Neurosciences Clinical Research Unit

    San Francisco, California 94158
    United States

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  • University of California, San Francisco Neurosciences Clinical Research Unit

    San Francisco 5391959, California 5332921 94158
    United States

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  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado 80113
    United States

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  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood 5421250, Colorado 5417618 80113
    United States

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  • Yale New Haven Health

    North Haven, Connecticut 06473
    United States

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  • Yale New Haven Health

    North Haven 4839704, Connecticut 4831725 06473
    United States

    Active - Recruiting

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

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • University of Florida Norman Fixel Institute for Neurological Diseases

    Gainesville, Florida 32608
    United States

    Site Not Available

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

    Boca Raton 4148411, Florida 4155751 33486
    United States

    Active - Recruiting

  • University of Florida Norman Fixel Institute for Neurological Diseases

    Gainesville 4156404, Florida 4155751 32608
    United States

    Active - Recruiting

  • Indiana Health University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana Health University

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • QUEST Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • QUEST Research Institute

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • University Nebraska Medical Center

    Omaha, Nebraska 68198-8440
    United States

    Site Not Available

  • University Nebraska Medical Center

    Omaha 5074472, Nebraska 5073708 68198-8440
    United States

    Active - Recruiting

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

    New York, New York 10032-3726
    United States

    Site Not Available

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

    New York 5128581, New York 5128638 10032-3726
    United States

    Active - Recruiting

  • Cleveland Clinic - Neurological Institute

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Cleveland Clinic - Neurological Institute

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University Of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • University Of Pittsburgh

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center-Cognitive and Movement Disorders Group

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University Medical Center-Cognitive and Movement Disorders Group

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Baylor College Of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

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

    Dallas 4684888, Texas 4736286 75390-8565
    United States

    Active - Recruiting

  • Baylor College Of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Inland Northwest Research

    Spokane, Washington 99202
    United States

    Site Not Available

  • Inland Northwest Research

    Spokane 5811696, Washington 5815135 99202
    United States

    Active - Recruiting

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