A Study of Lu AF82422 in Participants With Multiple System Atrophy (AMULET)

JRCT ID: jRCT2021210061

Registered date:07/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Multiple System Atrophy
• Date of first enrollment: 22/03/2022
• Target sample size: 60
• Countries of recruitment: US,Japan
• Study type: Interventional
• Intervention(s): 4.2g of Lu AF82422 is administered once every 4 weeks for 30 minutes from the start of treatment through Week 48, from Week 49 onward until the last subject has completed Week 48, up to a maximum of 72 weeks.

Outcome(s)

• Primary Outcome: Change From Baseline in the Unified Multiple System Atrophy Rating Scale (UMSARS) Part I and Part II Total Score (UMSARS TS) at the End of Treatment (EOT) [ Time Frame: Baseline, EOT (Week 48 to 72) ]

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 75age old
• Gender: Both

Include 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 question 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.

Exclude criteria

-The participant has been treated with an anti-alpha-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of alpha-synuclein aggregation within the last 12 months.
-The participant has any past or current treatment with an active vaccine targeting alpha-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.

Related Information

• Primary Sponsor: Yazawa Masanari
• Secondary ID(s): NCT05104476