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A Study of Lu AF82422 in Participants With Multiple System Atrophy (AMULET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05104476
Recruitment Status : Active, not recruiting
First Posted : November 3, 2021
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
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Brief Summary:
To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: Lu AF82422 Drug: Placebo Phase 2

Detailed Description:
The participants will be randomized to Lu AF82422 or placebo (2:1).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : November 20, 2023
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lu AF82422
Participants will receive Lu AF82422 intravenous (IV) infusion every 4 weeks (Q4W) from Baseline for a minimum 48 weeks up to a maximum 72 weeks.
 Drug: Lu AF82422
Solution for infusion
Experimental: Placebo
Participants will receive Lu AF82422 matching placebo IV infusion Q4W from Baseline for a minimum 48 weeks up to a maximum 72 weeks.
 Drug: Placebo
Solution for infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: Baseline, EOT (Week 48 to 72) ]

Secondary Outcome Measures :
  1. Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT [ Time Frame: Baseline, EOT (Week 48 to 72) ]
  2. Change From Baseline in the UMSARS Part I and UMSARS Part II Scores at the EOT [ Time Frame: Baseline, EOT (Week 48 to 72) ]
  3. Change From Baseline in UMSARS TS, UMSARS Part I, mUMSARS and UMSARS Part II Scores at Week 48 [ Time Frame: Baseline, Week 48 ]
  4. Change From Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  5. Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  6. Change From Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  7. Change From Baseline in Observer-Reported Global Impression - Severity of Illness (OGI-S) Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  8. Change From Baseline in Composite Autonomic Symptom Score Select Change (COMPASS Select Change) Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  9. Change From Baseline in UMSARS Part IV Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  10. Change From Baseline in Speech, Swallowing, Falls, and Walking, as Assessed by the UMSARS Part I Item Scores at Week 48 [ Time Frame: Baseline, Week 48 ]
  11. Change From Baseline in Frequency, Cause, and Consequence of Falls, as Assessed by the Fall Diary Periods at Week 48 [ Time Frame: Baseline, Week 48 ]
  12. Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  13. Percent Change From Baseline in Brain Volume, as Measured by Volumetric MRI (vMRI) at Week 48 [ Time Frame: Baseline, Week 48 ]
  14. Change From Baseline in Neurofilament Light Chain (NfL) Concentrations at Week 48 [ Time Frame: Baseline, Week 48 ]
  15. Lu AF82422 Plasma Concentration [ Time Frame: 0 to Week 88 ]
  16. Lu AF82422 Cerebrospinal Fluid (CSF) Concentrations [ Time Frame: Weeks 48 ]
  17. Lu AF82422 CSF/Plasma Concentration Ratio [ Time Frame: Week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Key Exclusion Criteria:

  • The participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months.
  • The participant has any past or current treatment with an active vaccine targeting α-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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05104476


Locations
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Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S H. Lundbeck A/S
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT05104476    
Other Study ID Numbers: 18331A
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lundbeck A/S:
Multiple System Atrophy
Neurodegenerative Disorder
Autonomic Failure
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases