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

Description

The main goal of this trial is to evaluate the efficacy and safety of Lu AF82422 for the treatment of participants with Multiple System Atrophy (MSA).

Conditions

Multiple System Atrophy

Study Overview

Study Details

Study overview

The main goal of this trial is to evaluate the efficacy and safety of Lu AF82422 for the treatment of participants with Multiple System Atrophy (MSA).

Interventional, Randomized, Double-blind, Placebo-controlled, Optional Open-label Extension Trial of Lu AF82422 in Participants With Multiple System Atrophy

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

Condition
Multiple System Atrophy
Intervention / Treatment

-

Contacts and Locations

Englewood

CenExel Rocky Mountain Clinical Research, LLC, Englewood, Colorado, United States, 80113

Farmington Hills

QUEST Research Institute, Farmington Hills, Michigan, United States, 48334

Spokane

Inland Northwest Research, Spokane, Washington, United States, 99202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

40 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lundbeck A/S,

Email contact via H. Lundbeck A/S, STUDY_DIRECTOR, H. Lundbeck A/S

Study Record Dates

2029-10-25