A Study of Lu AF82422 in Participants With Multiple System Atrophy

Launched by H. LUNDBECK A/S · Oct 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Lu AF82422 to see how it affects people with Multiple System Atrophy (MSA), a rare neurological condition that impacts movement and other bodily functions. The trial is currently active but not recruiting new participants. It primarily targets adults aged 18 to 80 who have been diagnosed with either the parkinsonian type (MSA-P) or cerebellar type (MSA-C) of MSA and have experienced symptoms for five years or less. To be eligible, participants should also have certain cognitive abilities and a specific score that measures their motor function.

Participants in this trial can expect to take the medication over a set period and attend regular check-ups where their health will be monitored. It’s important that they haven't recently received certain other treatments for MSA or have significant family histories of the disease. Overall, this study aims to gather more information on how Lu AF82422 might help slow down the progression of MSA, which could lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• 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.