Phase
Condition
Multiple System Atrophy
Treatment
Placebo
Lu AF82422
Clinical Study ID
Ages 40-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
The participant has a diagnosis of clinically established multiple system atrophyparkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C), orclinically 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/orcerebellar) within 5 years prior to the Screening Visit in the judgement of theinvestigator.
The participant has an anticipated survival of >3 years, in the opinion of theinvestigator, at the Screening Visit.
The participant has suitable peripheral venous access for investigational medicinalproduct (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
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 byother 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, progressivesupranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasaldegeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, perinvestigator discretion. Participants who have previously been incorrectly diagnosedwith Parkinson's disease will not be excluded.
Other protocol-defined inclusion and exclusion criteria apply.
Study Design
Study Description
Connect with a study center
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado 80113
United StatesActive - Recruiting
Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton, Florida 33486
United StatesActive - Recruiting
QUEST Research Institute
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Inland Northwest Research
Spokane, Washington 99202
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.