Phase
Condition
Neurologic Disorders
Multiple System Atrophy
Multiple Sclerosis
Treatment
Placebo
Lu AF82422
Clinical Study ID
Ages 40-75 All Genders
Study Summary
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
Study Description
Connect with a study center
Liverpool Hospital - South Western Sydney Local Health District
Liverpool, New South Wales 2170
AustraliaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Liverpool Hospital - South Western Sydney Local Health District
Liverpool 2159851, New South Wales 2155400 2170
AustraliaActive - Recruiting
Westmead Hospital
Westmead 2143973, New South Wales 2155400 2145
AustraliaActive - Recruiting
Gold Coast Hospital
Southport, Queensland 4215
AustraliaSite Not Available
Gold Coast Hospital
Southport 2148928, Queensland 2152274 4215
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 3004
AustraliaActive - Recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux 3031582, 33076
FranceActive - Recruiting
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
Lille, 59037
FranceSite Not Available
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
Lille 2998324, 59037
FranceActive - Recruiting
CHU - Hospital de la Timone
Marseille 2995469, 13385
FranceActive - Recruiting
Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac
Montpellier, 34295
FranceSite Not Available
Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac
Montpellier 2992166, 34295
FranceActive - Recruiting
Chu De La Pitie-Salpetriere
Paris, 75651
FranceSite Not Available
Chu De La Pitie-Salpetriere
Paris 2988507, 75651
FranceActive - Recruiting
Unite d'investigation clinique de Neurologie Rez-de-jardin-Bloc Hopital CHU Pontchaillou
Rennes 2983990, 35033
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, 31059
FranceSite Not Available
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse 2972315, 31059
FranceActive - Recruiting
Movement Disorders Clinic
Beelitz-Heilstatten, 14547
GermanySite Not Available
Movement Disorders Clinic
Beelitz-Heilstätten 2951592, 14547
GermanyActive - Recruiting
Universitaetsklinikum Erlangen
Erlangen, 91054
GermanySite Not Available
Universitaetsklinikum Erlangen
Erlangen 2929567, 91054
GermanyActive - Recruiting
Curiositas-ad-sanum Beratungs-und Studien GmbH
Haag in Oberbayern, 83527
GermanySite Not Available
Curiositas-ad-sanum Beratungs-und Studien GmbH
Haag in Oberbayern 2913210, 83527
GermanyActive - Recruiting
University Hospital Tuebingen
Tuebingen, 72076
GermanySite Not Available
University Hospital Tuebingen
Tübingen 2820860, 72076
GermanyActive - Recruiting
IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
Bologna, 40139
ItalySite Not Available
IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
Bologna 3181928, 40139
ItalyActive - Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
ItalySite Not Available
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan 3173435, 20122
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan 3173435, 20133
ItalyActive - Recruiting
AOU Universita della Campania Luigi Vanvitelli
Napoli 9031661, 80138
ItalyActive - Recruiting
A.O.U. Pisana-Ospedale S. Chiara
Pisa, 56126
ItalySite Not Available
A.O.U. Pisana-Ospedale S. Chiara
Pisa 3170647, 56126
ItalyActive - Recruiting
Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona
Salerno, 84100
ItalySite Not Available
Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona
Salerno 3168673, 84100
ItalyActive - Recruiting
Fujita Health University Hospital
Toyoake 6822210, Aichi-ken 1865694 470-1192
JapanActive - Recruiting
Gifu University Hospital
Gifu City, Gifu 501-1194
JapanSite Not Available
Gifu University Hospital
Gifu 1863641, Gifu 1863640 501-1194
JapanActive - Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
JapanSite Not Available
Hokkaido University Hospital
Sapporo 2128295, Hokkaido 2130037 060-8648
JapanActive - Recruiting
National Hospital Organization Sendai Nishitaga Hospital
Sendai, Miyagi 982-8555
JapanSite Not Available
National Hospital Organization Sendai Nishitaga Hospital
Sendai 2111149, Miyagi 2111888 982-8555
JapanActive - Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo 1850144 113-8431
JapanActive - Recruiting
National Center Hospital, National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo 1850144 187-8551
JapanActive - Recruiting
Tottori University Hospital
Yonago-shi, Tottori 1849890 683-8504
JapanActive - Recruiting
Saitama Medical University Hospital
Iruma-gun, 350-0495
JapanActive - Recruiting
Niigata University Medical And Dental Hospital
Niigata, 9518520
JapanSite Not Available
Niigata University Medical And Dental Hospital
Niigata 1855431, 9518520
JapanActive - Recruiting
Keio University Hospital
Tokyo, 160-8582
JapanSite Not Available
Keio University Hospital
Tokyo 1850147, 160-8582
JapanActive - Recruiting
Kyung Hee University Hospital
Seoul, 02447
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Kyung Hee University Hospital
Seoul 1835848, 02447
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul 1835848, 03722
South KoreaActive - Recruiting
Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN)
Barcelona, 08036
SpainSite Not Available
Hospital Universitario Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN)
Barcelona 3128760, 08036
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona (Spain), 08041
SpainSite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona (Spain) 3128760, 08041
SpainActive - Recruiting
Hospital Universitario de La Princesa
Madrid, 28006
SpainSite Not Available
Hospital Universitario de La Princesa
Madrid 3117735, 28006
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Sevilla, 41015
SpainSite Not Available
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville 2510911, 41015
SpainActive - Recruiting
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...
Valencia, 46026
SpainSite Not Available
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...
Valencia 2509954, 46026
SpainActive - Recruiting
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester M6 8HD
United KingdomSite Not Available
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford 2638671, Greater Manchester M6 8HD
United KingdomActive - Recruiting
Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Ho...
Oxford 2640729, Oxfordshire OX3 9DU
United KingdomActive - Recruiting
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde
Glasgow, Scotland G51 4TF
United KingdomSite Not Available
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hosp...
Glasgow, Scotland G51 4TF
United KingdomActive - Recruiting
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde
Glasgow 2648579, Scotland 2638360 G51 4TF
United KingdomActive - Recruiting
Clinical Ageing Reseach Unit
Newcastle upon Tyne, Tyne And Wear NE4 5LP
United KingdomSite Not Available
Clinical Ageing Reseach Unit
Newcastle upon Tyne 2641673, Tyne and Wear NE4 5LP
United KingdomActive - Recruiting
Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust
Exeter 2649808, EX2 5DW
United KingdomActive - Recruiting
The National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
United KingdomSite Not Available
The National Hospital for Neurology and Neurosurgery
London 2643743, WC1N 3BG
United KingdomActive - Recruiting
Mayo Clinic
Scottsdale, Arizona 85259
United StatesSite Not Available
Mayo Clinic
Scottsdale 5313457, Arizona 5551752 85259
United StatesActive - Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
University of California, San Francisco Neurosciences Clinical Research Unit
San Francisco, California 94158
United StatesSite Not Available
University of California, San Francisco Neurosciences Clinical Research Unit
San Francisco 5391959, California 5332921 94158
United StatesActive - Recruiting
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado 80113
United StatesSite Not Available
CenExel Rocky Mountain Clinical Research, LLC
Englewood 5421250, Colorado 5417618 80113
United StatesActive - Recruiting
Yale New Haven Health
North Haven, Connecticut 06473
United StatesSite Not Available
Yale New Haven Health
North Haven 4839704, Connecticut 4831725 06473
United StatesActive - Recruiting
Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton, Florida 33486
United StatesSite Not Available
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville, Florida 32608
United StatesSite Not Available
Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton 4148411, Florida 4155751 33486
United StatesActive - Recruiting
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville 4156404, Florida 4155751 32608
United StatesActive - Recruiting
Indiana Health University
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana Health University
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
QUEST Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
QUEST Research Institute
Farmington Hills 4992523, Michigan 5001836 48334
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
University Nebraska Medical Center
Omaha, Nebraska 68198-8440
United StatesSite Not Available
University Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198-8440
United StatesActive - Recruiting
Columbia University Medical Center - The Neurological Institute of New York
New York, New York 10032-3726
United StatesSite Not Available
Columbia University Medical Center - The Neurological Institute of New York
New York 5128581, New York 5128638 10032-3726
United StatesActive - Recruiting
Cleveland Clinic - Neurological Institute
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic - Neurological Institute
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University Of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
University Of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
Vanderbilt University Medical Center-Cognitive and Movement Disorders Group
Nashville, Tennessee 37232
United StatesSite Not Available
Vanderbilt University Medical Center-Cognitive and Movement Disorders Group
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
Baylor College Of Medicine
Houston, Texas 77030
United StatesSite Not Available
University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic
Dallas 4684888, Texas 4736286 75390-8565
United StatesActive - Recruiting
Baylor College Of Medicine
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Inland Northwest Research
Spokane, Washington 99202
United StatesSite Not Available
Inland Northwest Research
Spokane 5811696, Washington 5815135 99202
United StatesActive - Recruiting
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