Summary

Eligibility
for people ages 40-75 (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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).

Official Title

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

Details

This study will consist of a 3-6-week screening period, a 72-week placebo-controlled period (PCP), and will include a 72-week optional dose-blinded open-label treatment extension (OLE) period. Participants in the PCP will be randomized to Lu AF82422 high dose, Lu AF82422 low dose or placebo (1:1:1). All participants entering the OLE will receive Lu AF82422 during the OLE. Participants will receive intravenous infusions approximately every 4 weeks during both the PCP and OLE.

Keywords

Multiple System Atrophy, Lu AF82422, MSA, Neurodegenerative Disorder, Neurodegenerative Diseases, Counterfeit Drugs

Eligibility

You can join if…

Open to people ages 40-75

  • 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.

You CAN'T join if...

  • 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.

Other protocol-defined inclusion and exclusion criteria apply.

Locations

  • University of California, San Francisco Neurosciences Clinical Research Unit accepting new patients
    San Francisco 5391959 California 5332921 94158 United States
  • Mayo Clinic accepting new patients
    Scottsdale 5313457 Arizona 5551752 85259 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
H. Lundbeck A/S
ID
NCT06706622
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated