To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
Eligibility
Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria:
* The participant is diagnosed with possible or probable MSA of the multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C) sub-type at the Screening Visit.
* The participant had onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator.
* The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit.
* The participant has a cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score ≥22 at the Screening Visit.
Open-label Extension Entry Criteria
* The participant has completed the EoT Visit and did not withdraw in the DBP.
* The participant has consented to participate in the OLE.
* The participant has completed the DBP within the last 5 months and will be enrolled into the OLE no later than end of Q1 2024.
* The participant is, in the Investigator's opinion, likely to comply with the protocol.
* The participant has not received any other Investigational product since the EOoTDBP Visit.
Key Exclusion Criteria:
* The participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months.
* The participant has any past or current treatment with an active vaccine targeting α-synuclein.
* The participant has 2 or more blood relatives with a history of MSA.
* The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).
* The participant has a current diagnosis of movement disorders that could mimic MSA (for example, Parkinson' 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.
Other inclusion and exclusion criteria may apply.
Primary outcome measure(s)
Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP) — Baseline up to Week 72 The primary endpoint assessed disease progression by a Bayesian repeated measures model on UMSARS TS. Reported here is the estimated slowing (%) of clinical progression in participants receiving Lu AF82422 relative to those receiving placebo. UMSARS is a combined clinician and patient-reported outcome assessment developed to provide a surrogate measure of disease progression in multiple system atrophy (MSA). UMSARS TS was obtained by the sum of the items from Part I and Part II. Part I assesses historical information on symptoms and activities of daily living over the past 2 weeks and Part II consists of a clinical examination of key MSA motor signs and symptoms. UMSARS TS score was the sum of all items and ranged from 0 (no impairment) to 104 (severe impairment). A higher score indicated greater impairment.
Trial sites (19)
Facility
City
Region
Status
The Parkinsons and Movement Disorder Institute
Fountain Valley
California
University of California - San Diego
La Jolla
California
University of California, San Francisco Neurosciences Clinical Research Unit
San Francisco
California
CenExel Rocky Mountain Clinical Research, LLC
Englewood
Colorado
Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton
Florida
University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville
Florida
Rush University Medical Center, Rush University Cancer Center
Chicago
Illinois
Endeavor Health - Glenbrook Hospital
Glenview
Illinois
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Mayo Clinic
Rochester
Minnesota
University Nebraska Medical Center
Omaha
Nebraska
NYU Langone Health Medical Center
New York
New York
Columbia University Medical Center - The Neurological Institute of New York
New York
New York
Penn State Milton S. Hershey Medical Center - Penn State Hershey Neuroscience Institute (PSHNI)
Hershey
Pennsylvania
University of Pennsylvania
Philadelphia
Pennsylvania
University Of Pittsburgh
Pittsburgh
Pennsylvania
Fujita Health University Hospital
Toyoake
Aichi-ken
Gifu University Hospital
Gifu
Gifu
National Hospital Organization Sendai Nishitaga Hospital
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.
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