Trials / Active Not Recruiting
Active Not RecruitingNCT05104476
A Study of Lu AF82422 in Participants With Multiple System Atrophy
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.
Detailed description
This study will consist of a double-blind period (DBP) and will include an optional open-label treatment extension (OLE) period. Participants in the DBP will be randomized to Lu AF82422 or placebo (2:1). All participants entering the OLE will receive Lu AF82422 during the OLE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AF82422 | Solution for infusion |
| DRUG | Placebo | Solution for infusion |
Timeline
- Start date
- 2021-11-16
- Primary completion
- 2023-11-16
- Completion
- 2028-03-07
- First posted
- 2021-11-03
- Last updated
- 2026-04-13
- Results posted
- 2024-12-27
Locations
19 sites across 2 countries: United States, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05104476. Inclusion in this directory is not an endorsement.