Multiple System Atrophy
Conditions
Interventions
In the Double-blind Treatment Period, Lu AF82422 high dose, Lu AF82422 low dose or placebo is administered once every 4 weeks for 30 minutes from the start of treatment through Week 72.
In the Open-la
Sponsors
Yazawa Masanari
Eligibility
Sex/Gender
All
Inclusion criteria
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 (i.e., 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 or less (omitting item 11 on sexual function) at the Screening Visit.
Exclusion criteria
Exclusion criteria: - The participant has previously been dosed with Lu AF82422. - The participant has taken any IMP <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' 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score [Time Frame: Baseline up to Week 72] | — |
Countries
Australia, Canada, France, Germany, Italy, Japan, Republic of Korea, Spain, United Kingdom, United States
Contacts
Public ContactContact
Lundbeck Japan K.K.
Outcome results
None listed