Clinical Trials in Japan / NCT05104476
Active, not recruiting
Phase 2
A Study of Lu AF82422 in Participants With Multiple System Atrophy
NCT05104476 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Multiple System Atrophy
Investigational drug(s) / intervention(s)
Lu AF82422 →Placebo
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
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 | Sendai | Miyagi |
More H. Lundbeck A/S trials in Japan
A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
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Other trials for the same condition
A Phase 2 Study of YA-101 in Patients With Multiple System Atrophy
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A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
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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 Japan