A Study to Assess the Effectiveness, Safety and Tolerability of Lu AF82422 in Patients with Multiple System Atrophy

Overview

About this study

The purpose of this study is to evaluate the effectiveness of Lu AF82422 on disease progression in patients with Multiple System Atrophy (MSA).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Exclusion Criteria:

- The participant has been treated with an anti-?-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of ?-synuclein aggregation within the last 12 months.

- The participant has any past or current treatment with an active vaccine targeting 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.

Eligibility last updated 7/22/22 to match clinicaltrials.gov. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wolfgang Singer, M.D.

Open for enrollment

Contact information:

Raelene Martini

(507) 284-0336

adc.research@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20527083

Mayo Clinic Footer