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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple System Atrophy

In brief

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).

Key facts

Study ID

NCT06706622

Run by

H. Lundbeck A/S

People needed

401

Starts

2024-12-03

Expected to finish

2029-10-25

Last updated by the study team

2026-07-14

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• 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
• Mayo Clinic — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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