Interventional randomized double-blind parallel-group placebo-controlled multi-centre study to assess the efficacy safety and tolerability of Lu AF82422 in patients with Multiple System Atrophy
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Multiple System Atrophy
-
Age: Between 40 Year(s) - 75 Year(s)
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Diagnosis of possible or probable MSA of the parkinsonian sub-type (MSA-P) or cerebellar sub-type
- Less than 5 years from the time of onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms
- Anticipated survival of at least 3 years, in the opinion of the investigator, at the Screening Visit
- An UMSARS Part I score =16 (omitting question 11 on sexual function)
- Cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score =22
- The patient has a knowledgeable and reliable caregiver who will be available throughout the study when carer/observer-reported outcomes are performed.
You may not be eligible for this study if the following are true:
-
- Treatment with an anti-a-synuclein monoclonal antibody or an inhibitor of a-synuclein aggregation within the last 12 months
- Any past or current treatment with an active vaccine targeting a-synuclein
- The patient has two or more blood relatives with a history of MSA
- Evidence (clinically or on MRI) and/or history of any serious neurological disorder, other intracranial or systemic diseases or conditions resulting in a diagnosis other than MSA
- Current diagnosis of movement disorders that could mimic MSA
- History of severe drug allergy, anaphylaxis or hypersensitivity or known hypersensitivity or intolerance to the IMP or its excipients
- History of neurosurgical procedures including deep brain stimulation that could, in the investigator’s opinion, interfere with the assessments of safety or efficacy
- Contraindications for MRI
- Attempted suicide within the past 6 months or is at significant risk of suicide
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.