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Clinical Trials in the USA / NCT05104476
Active, not recruiting Phase 2

A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT05104476 · tracked via the Priya Life Science USA tracker
Sponsor
H. Lundbeck A/S
Phase
Phase 2
Started
2021-11-16
Last updated
2026-04-13

Condition(s) studied

Multiple System Atrophy

Investigational drug(s) / intervention(s)

Lu AF82422Placebo

Lu AF82422: Solution for infusion

Placebo: Solution for infusion

Study summary

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)

Trial sites (19)

FacilityCityRegionStatus
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 Sendai Miyagi

More H. Lundbeck A/S trials in the USA

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 NCT05104476 on ClinicalTrials.gov ↗ ← All trials in the USA