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Clinical Trials in the UK / NCT06706622
Active, not recruiting Phase 3

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

NCT06706622 · tracked via the Priya Life Science UK tracker
Sponsor
H. Lundbeck A/S
Phase
Phase 3
Started
2024-12-03
Last updated
2026-07-14

Condition(s) studied

Multiple System Atrophy

Investigational drug(s) / intervention(s)

AmlenetugPlacebo

Amlenetug: Solution for infusion

Placebo: Commercially available saline solution

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
Mayo Clinic Scottsdale Arizona
University of Arkansas for Medical Sciences Little Rock Arkansas
University of California, San Francisco Neurosciences Clinical Research Unit San Francisco California
CenExel Rocky Mountain Clinical Research, LLC Englewood Colorado
Yale New Haven Health North Haven Connecticut
Parkinson's Disease And Movement Disorder Center Of Boca Raton Boca Raton Florida
University of Florida Norman Fixel Institute for Neurological Diseases Gainesville Florida
Indiana Health University Indianapolis Indiana
Johns Hopkins University School of Medicine Baltimore Maryland
Brigham and Women's Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
QUEST Research Institute Farmington Hills Michigan
Mayo Clinic Rochester Minnesota
University Nebraska Medical Center Omaha Nebraska
NYU Medical Center - Dysautonomia center New York New York
Columbia University Medical Center - The Neurological Institute of New York New York New York
Cleveland Clinic - Neurological Institute Cleveland Ohio
University of Pennsylvania Philadelphia Pennsylvania
University Of Pittsburgh Pittsburgh Pennsylvania
Vanderbilt University Medical Center-Cognitive and Movement Disorders Group Nashville Tennessee
University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic Dallas Texas
Baylor College Of Medicine Houston Texas
Inland Northwest Research Spokane Washington
Liverpool Hospital - South Western Sydney Local Health District Liverpool New South Wales
Westmead Hospital Westmead New South Wales
Gold Coast Hospital Southport Queensland
The Alfred Hospital Melbourne Victoria
The Ottawa Hospital Research Institute Ottawa Ontario
Toronto Western Hospital (TWH) Toronto Ontario
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 GmbH Haag in Oberbayern Germany
Ludwig-Maximilians-Universitat Munchen Klinikum der Universitat - Grosshadern München Germany

+ 34 more sites — see the full list on the official registry below.

More H. Lundbeck A/S trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06706622 on ClinicalTrials.gov ↗ ← All trials in the UK