臨床研究等提出・公開システム

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)

Yazawa Masanari

Lundbeck Japan K.K.

Kamiyacho Prime Place, 4-1-17 Toranomon, Minato-ku, Tokyo, Japan

chiken@lundbeck.com

Contact

Lundbeck Japan K.K.

Kamiyacho Prime Place, 4-1-17 Toranomon, Minato-ku, Tokyo, Japan

+81-3-5733-8690

japan@lundbeck.com

Not Recruiting

Mar. 06, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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 or less (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.

Both

Multiple System Atrophy

In the Double-blind Treatment Period, Lu AF82422 high dose, Lu AF82422 low dose or placebo is administered once every 4 weeks for 30 minutes from the start of treatment through Week 72.
In the Open-label Extension Treatment Period, Lu AF82422 high dose or Lu AF82422 low dose is administered once every 4 weeks for 30 minutes from the start of treatment from Week 72 to Week 144.

Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score [Time Frame: Baseline up to Week 72]

+81-22-245-2111

Jan. 24, 2025

No

Canada/France/Germany/Italy/Republic of Korea/Spain/United Kingdom/United States/Australia