Lu AF82422 in participants with MSA: 20432A (MASCOT)
Research type
Research Study
Full title
Interventional, randomized, double-blind, placebo-controlled, optional open-label extension trial of Lu AF82422 in participants with Multiple System Atrophy
IRAS ID
1011354
Contact name
H. Lundbeck A/S
Contact email
Sponsor organisation
H. Lundbeck A/S
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out whether a potential new treatment, the active drug, Lu AF82422, is safe and effective in people living with Multiple system atrophy (MSA). This study will compare the effects of the investigational drug, Lu AF82422, to placebo (inactive medication). The study will start with a Placebo-Controlled Period (PCP) and participants will have a 66% chance of being assigned to the investigational drug during the Placebo-controlled period (PCP). The PCP will last for approximately 22 months and will involve 20 visits to the study site. The PCP is 'double-blind' which means that neither the participant or study doctor will know whether the participant is receiving to the active drug or placebo. This is done to make sure the results of the study cannot be influenced by anyone. If there is an urgent need, a treating physician or study doctor can find out quickly which study drug the participant is receiving. After the PCP ends there is an optional Open-Label extension (OLE) for participants who complete the PCP where all participants will receive the investigational drug for an additional 16 months and will involve an additional 17 visits to the study site.
The study will be split into time periods as follows:
Screening (Visit 1, 3-6 weeks)
Placebo-Controlled Period (Visit 2-20, from end of screening to week 72)
Open- label extension period (Visit 20-38, week 72-144)
Study procedures will include: Having blood and urine samples taken, having Cerebrospinal (CSF) fluid taken via lumbar puncture, physical and neurological examinations, olfactory (smell) tests, ECGs, MRI scans, blood and urine pregnancy tests (only for people who are able to get pregnant) and questionnaire completion.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0202
Date of REC Opinion
21 Jan 2025
REC opinion
Further Information Favourable Opinion