Lu AF82422 for Multiple System Atrophy
(AMULET Trial)

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lundbeck A/S

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called Lu AF82422 to see if it can slow down the progression of multiple system atrophy (MSA). MSA is a rare and worsening neurological condition, and current treatments may not be effective. The study will compare the new drug to determine its effectiveness.

Eligibility Criteria

This trial is for individuals with multiple system atrophy (MSA) diagnosed within the last 5 years, having motor or autonomic symptoms. They should have a UMSARS Part I score ≤16 and a MoCA score ≥22, indicating certain levels of physical and cognitive function. Participants must be likely to follow the study protocol and not have used other investigational products recently.

Inclusion Criteria

Your UMSARS Part I score is less than or equal to 16, excluding the item about sexual function.

The participant has not received any other Investigational product since the EOoTDBP Visit.

The participant is, in the Investigator's opinion, likely to comply with the protocol.

+7 more

Exclusion Criteria

I have not been treated with specific Parkinson's disease therapies in the last year.

I have been diagnosed with a movement disorder other than MSA.

I have no significant health issues other than MSA.

+2 more

Participant Groups

The study tests Lu AF82422's effect on disease progression in MSA patients against a placebo. It aims to understand if this drug can slow down the worsening of symptoms associated with MSA, which includes both parkinsonian (MSA-P) and cerebellar types (MSA-C).

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Participants in the DBP will receive Lu AF82422 matching placebo IV infusion Q4W from Baseline for a minimum 48 weeks up to a maximum 72 weeks.

Group II: Lu AF82422Experimental Treatment1 Intervention

Participants in the DBP will receive Lu AF82422 intravenous (IV) infusion every 4 weeks (Q4W) from Baseline for a minimum 48 weeks up to a maximum 72 weeks. In the optional OLE, all participants will receive Lu AF82422 IV infusion starting on Day 1 of the OLE up to week 92.

Lu AF82422 is already approved in United States, European Union, Japan, China for the following indications:

🇺🇸 Approved in United States as Lu AF82422 for: