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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06706622




Registration number
NCT06706622
Ethics application status
Date submitted
22/11/2024
Date registered
26/11/2024
Date last updated
15/06/2025

Titles & IDs
Public title
A Trial of Lu AF82422 in Participants With Multiple System Atrophy (MSA)
Scientific title
Interventional, Randomized, Double-blind, Placebo-controlled, Optional Open-label Extension Trial of Lu AF82422 in Participants With Multiple System Atrophy
Secondary ID [1] 0 0
2024-517169-18-00
Secondary ID [2] 0 0
20432A
Universal Trial Number (UTN)
Trial acronym
MASCOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple System Atrophy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Neurological 0 0 0 0
Neurodegenerative diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lu AF82422
Treatment: Drugs - Placebo

Experimental: Lu AF82422 Low Dose - Participants will receive Lu AF82422 by intravenous infusion

Experimental: Lu AF82422 High Dose - Participants will receive Lu AF82422 by intravenous infusion

Placebo comparator: Placebo - Participants will receive commercially available saline solution for infusion


Treatment: Drugs: Lu AF82422
Solution for infusion

Treatment: Drugs: Placebo
Commercially available saline solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Non-European Union (EU) Regional-specific Outcome Measure: Change from Baseline in modified Unified Multiple System Atrophy Rating Scale (mUMSARS) Score
Timepoint [1] 0 0
Baseline up to Week 72
Primary outcome [2] 0 0
EU Regional-specific Outcome Measure: Change from Baseline in Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (TS)
Timepoint [2] 0 0
Baseline up to Week 72
Secondary outcome [1] 0 0
Change from Baseline in UMSARS TS
Timepoint [1] 0 0
Baseline up to Week 72
Secondary outcome [2] 0 0
Change from Baseline in UMSARS Part I Score
Timepoint [2] 0 0
Baseline up to Week 72
Secondary outcome [3] 0 0
Change from Baseline in UMSARS Part II Score
Timepoint [3] 0 0
Baseline up to Week 72
Secondary outcome [4] 0 0
Change from Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score
Timepoint [4] 0 0
Baseline, Week 72
Secondary outcome [5] 0 0
Change from Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score
Timepoint [5] 0 0
Baseline, Week 72
Secondary outcome [6] 0 0
Change from Baseline in Observer-reported Global Impression-Severity of Illness (OGI-S) Score
Timepoint [6] 0 0
Baseline, Week 72
Secondary outcome [7] 0 0
Change from Baseline in UMSARS Part IV Score
Timepoint [7] 0 0
Baseline, Week 72
Secondary outcome [8] 0 0
Change from Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score
Timepoint [8] 0 0
Baseline, Week 72
Secondary outcome [9] 0 0
Change from Baseline in UMSARS Part I Item 1: Speech Score
Timepoint [9] 0 0
Baseline, Week 72
Secondary outcome [10] 0 0
Change from Baseline in EuroQol 5-dimensions, 5-levels (EQ-5D-5L) Domain Score
Timepoint [10] 0 0
Baseline, Week 72
Secondary outcome [11] 0 0
Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score
Timepoint [11] 0 0
Baseline, Week 72
Secondary outcome [12] 0 0
Change from Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Questionnaire Domain Scores
Timepoint [12] 0 0
Baseline, Week 72
Secondary outcome [13] 0 0
Combined Clinical Progression and Survival Score
Timepoint [13] 0 0
Baseline, Week 72
Secondary outcome [14] 0 0
Time from Baseline to Death (Any Cause)
Timepoint [14] 0 0
Baseline up to Week 72
Secondary outcome [15] 0 0
Number of Participants with an Absolute Increase in mUMSARS Score of <5, <7, and <9 points
Timepoint [15] 0 0
Baseline, Week 72
Secondary outcome [16] 0 0
Number of Participants with an Absolute Increase in UMSARS TS of <16, <21, and <26 Points
Timepoint [16] 0 0
Baseline, Week 72
Secondary outcome [17] 0 0
Percentage Change from Baseline in Brain Volume in Brain Regions of Interest (ROIs)
Timepoint [17] 0 0
Baseline, Week 72
Secondary outcome [18] 0 0
Area Under the Curve (AUC) of Lu AF82422
Timepoint [18] 0 0
Baseline up to Week 72
Secondary outcome [19] 0 0
Maximum Observed Concentration (Cmax) of Lu AF82422
Timepoint [19] 0 0
Baseline up to Week 72
Secondary outcome [20] 0 0
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [20] 0 0
Day 1 up to Week 144
Secondary outcome [21] 0 0
Number of Participants with Anti-Lu AF82422 Antibodies (ADAs)
Timepoint [21] 0 0
Baseline up to Week 144

Eligibility
Key inclusion criteria
Key

* 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.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2029
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - South Western Sydney Local Health District - Liverpool
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Montpellier
Country [14] 0 0
France
State/province [14] 0 0
Toulouse
Country [15] 0 0
Germany
State/province [15] 0 0
Haag in Oberbayern
Country [16] 0 0
Japan
State/province [16] 0 0
Hokkaido
Country [17] 0 0
Japan
State/province [17] 0 0
Miyagi
Country [18] 0 0
Japan
State/province [18] 0 0
Tokyo
Country [19] 0 0
Japan
State/province [19] 0 0
Tottori
Country [20] 0 0
Japan
State/province [20] 0 0
Niigata
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
H. Lundbeck A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
H. Lundbeck A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
Country 0 0
Phone 0 0
+45 36301311
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06706622