A Trial of Lu AF82422 in Participants With Multiple System Atrophy (MSA)

Launched by H. LUNDBECK A/S · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Lu AF82422 for people with Multiple System Atrophy (MSA), a rare neurological condition that affects movement and balance. The main goal of the trial is to find out if Lu AF82422 is safe and effective for patients diagnosed with either the parkinsonian type (MSA-P) or cerebellar type (MSA-C) of MSA. The trial is currently recruiting participants aged between 14 and 27 years.

To be eligible for the trial, participants must have been diagnosed with MSA within the last five years and have certain motor symptoms. They also need to have a good chance of living for more than three years and must be able to receive the treatment through their veins. Participants who have previously taken Lu AF82422 or have certain other medical conditions will not be eligible. Those who join the trial can expect to receive the new treatment and be closely monitored by medical professionals to assess how well it works and if there are any side effects.

Gender

ALL

Eligibility criteria

• Key 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 (omitting item 11 on sexual function) at the Screening Visit.
• 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.
• • Other protocol-defined inclusion and exclusion criteria apply.