A Study of Lu AF82422 in Participants With Multiple System Atrophy

Multiple System Atrophy Clinical Trial

— AMULET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05104476
• Other study ID #: 18331A
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 16, 2021
• Est. completion date: February 14, 2025

Study information

• Verified date: December 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: February 14, 2025
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• The participant is diagnosed with possible or probable MSA of the multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C) sub-type at the Screening Visit.
• The participant had onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator.
• The participant has an UMSARS Part I score =16 (omitting item 11 on sexual function) at the Screening Visit.
• The participant has a cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score =22 at the Screening Visit. Open-label Extension Entry Criteria
• The participant has completed the EoT Visit and did not withdraw in the DBP.
• The participant has consented to participate in the OLE.
• The participant has completed the DBP within the last 5 months and will be enrolled into the OLE no later than end of Q1 2024.
• The participant is, in the Investigator's opinion, likely to comply with the protocol.
• The participant has not received any other Investigational product since the EOoTDBP Visit.

Key Exclusion Criteria:

• The participant has been treated with an anti-a-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of a-synuclein aggregation within the last 12 months.
• The participant has any past or current treatment with an active vaccine targeting a-synuclein.
• The participant has 2 or more blood relatives with a history of MSA.
• The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).
• The participant has a current diagnosis of movement disorders that could mimic MSA (for example, 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. Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Drug:
• Lu AF82422
Solution for infusion
• Placebo
Solution for infusion

Locations

Country	Name	City	State
Japan	Gifu University Hospital	Gifu City	Gifu Prefecture
Japan	National Hospital Organization Sendai Nishitaga Hospital	Sendai-shi	Miyagi
Japan	Fujita Health University Hospital	Toyoake	Aichi
United States	Parkinson's Disease And Movement Disorder Center Of Boca Raton	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Rocky Mountain Movement Disorders Center	Englewood	Colorado
United States	The Parkinson's and Movement Disorder Institute	Fountain Valley	California
United States	University of Florida- Norman Fixel Institute for Neurological Diseases	Gainesville	Florida
United States	NorthShore University Healthsystem Neurological Institute	Glenview	Illinois
United States	Penn State Milton S. Hershey Medical Center - Penn State Hershey Neuroscience Institute (PSHNI)	Hershey	Pennsylvania
United States	University of California, San Diego	La Jolla	California
United States	Columbia University Medical Center - The Neurological Institute of New York	New York	New York
United States	NYU Medical Center - Dysautonomia center	New York	New York
United States	University Nebraska Medical Center	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University Of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	UCSF Memory and Aging Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Unified Multiple System Atrophy Rating Scale (UMSARS) Part I and Part II Total Score (UMSARS TS) at the End of Treatment (EOT) DBP		Baseline, EOTDBP (Week 48 to 72)
Secondary	Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP		Baseline, EOTDBP (Week 48 to 72)
Secondary	Change From Baseline in the UMSARS Part I and UMSARS Part II Scores at the EOT DBP		Baseline, EOTDBP (Week 48 to 72)
Secondary	Change From Baseline in UMSARS TS, UMSARS Part I, mUMSARS and UMSARS Part II Scores at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Observer-Reported Global Impression - Severity of Illness (OGI-S) Score at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Composite Autonomic Symptom Score Select Change (COMPASS Select Change) Score at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in UMSARS Part IV Score at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Speech, Swallowing, Falls, and Walking, as Assessed by the UMSARS Part I Item Scores at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Frequency, Cause, and Consequence of Falls, as Assessed by the Fall Diary Periods at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Score at Week 48 in the DBP		Baseline, Week 48
Secondary	Percent Change From Baseline in Brain Volume, as Measured by Volumetric MRI (vMRI) at Week 48 in the DBP		Baseline, Week 48
Secondary	Change From Baseline in Neurofilament Light Chain (NfL) Concentrations at Week 48 in the DBP		Baseline, Week 48
Secondary	Lu AF82422 Plasma Concentration		0 to Week 65 of the OLE
Secondary	Lu AF82422 Cerebrospinal Fluid (CSF) Concentrations in the DBP		Weeks 48
Secondary	Lu AF82422 CSF/Plasma Concentration Ratio in the DBP		Week 48