A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
NCT ID: NCT06706622
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2024-12-03
2029-10-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amlenetug Low Dose
Participants will receive amlenetug by intravenous infusion
Amlenetug
Solution for infusion
Amlenetug High Dose
Participants will receive amlenetug by intravenous infusion
Amlenetug
Solution for infusion
Placebo
Participants will receive commercially available saline solution for infusion
Placebo
Commercially available saline solution
Interventions
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Amlenetug
Solution for infusion
Placebo
Commercially available saline solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
75 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Email contact via H. Lundbeck A/S
Role: STUDY_DIRECTOR
H. Lundbeck A/S
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California, San Francisco Neurosciences Clinical Research Unit
San Francisco, California, United States
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, United States
Yale New Haven Health
North Haven, Connecticut, United States
Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton, Florida, United States
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, United States
Indiana Health University
Indianapolis, Indiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University Nebraska Medical Center
Omaha, Nebraska, United States
NYU Medical Center - Dysautonomia center
New York, New York, United States
Columbia University Medical Center - The Neurological Institute of New York
New York, New York, United States
Cleveland Clinic - Neurological Institute
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center-Cognitive and Movement Disorders Group
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic
Dallas, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Inland Northwest Research
Spokane, Washington, United States
Liverpool Hospital - South Western Sydney Local Health District
Liverpool, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Gold Coast Hospital
Southport, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Toronto Western Hospital (TWH)
Toronto, Ontario, Canada
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, , France
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
Lille, , France
CHU - Hospital de la Timone
Marseille, , France
Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac
Montpellier, , France
Chu De La Pitie-Salpetriere
Paris, , France
Unite d'investigation clinique de Neurologie Rez-de-jardin-Bloc Hopital CHU Pontchaillou
Rennes, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
Toulouse, , France
Movement Disorders Clinic
Beelitz-Heilstätten, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Curiositas-ad-sanum Beratungs-und Studien GmbH
Haag in Oberbayern, , Germany
Ludwig-Maximilians-Universitat Munchen Klinikum der Universitat - Grosshadern
München, , Germany
University Hospital Tuebingen
Tübingen, , Germany
IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
Bologna, , Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
AOU Universita della Campania Luigi Vanvitelli
Napoli, , Italy
A.O.U. Pisana-Ospedale S. Chiara
Pisa, , Italy
Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona
Salerno, , Italy
National Hospital Organization Higashinagoya National Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Sendai Nishitaga Hospital
Sendai, Miyagi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
National Center Hospital, National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo, Japan
Tottori University Hospital
Yonago-shi, Tottori, Japan
Saitama Medical University Hospital
Iruma-gun, , Japan
Niigata University Medical And Dental Hospital
Niigata, , Japan
Keio University Hospital
Tokyo, , Japan
Kyung Hee University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Centro de Esclerosis Mutiple de Cataluna (Cemcat) - Barcelona, ¿¿Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN)
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona (Spain), , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
Seville, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...
Valencia, , Spain
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester, United Kingdom
Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Ho...
Oxford, Oxfordshire, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde
Glasgow, Scotland, United Kingdom
Clinical Ageing Reseach Unit
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust
Exeter, , United Kingdom
The National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-517169-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
20432A
Identifier Type: -
Identifier Source: org_study_id