IRB Study Number 25-343
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Neurological Institute
Description
This trial aims to see if the investigational study drug (LU AF82422) is effective and safe in slowing the disease progression in people living with multiple system atrophy (MSA). The clinical trial will compare the study drug to a placebo (inactive medication). It will be given by intravenous (IV, or through a vein) infusion once every 4 weeks.
You will have the option of continuing in the "open-label extension" (OLE), where everyone will receive the investigational drug, even those who were receiving placebo up to this point.
Participation includes:
- Screening: 3-6 weeks
- Placebo-controlled period: 72 weeks
- Optional open-label period: 72 weeks
- Safety follow-up period: 20 weeks from last dose of study drug
Inclusion Criteria
- 40-75 years of age
- 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.
- 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.
- Suitable peripheral venous access for investigational medicinal product (IMP) administration and blood sampling.
- UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit.
Other criteria as listed in the protocol.
Exclusion Criteria
- Previously been dosed with Lu AF82422.
- Taken any IMP <3 months or <5 half lives of that product, whichever is longer, prior to the first dose of IMP.
- 2 or more first degree relatives with a history of MSA.
- 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 (if of MSA-P subtype)
- 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.
- 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.
