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Lu AF82422 for Multiple System Atrophy (AMULET Trial)
Phase 2
Waitlist Available
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Key
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, eotdbp (week 48 to 72)
Awards & highlights
AMULET Trial Summary
This trial is testing a new drug to see if it can help people with multiple system atrophy.
Who is the study for?
This trial is for individuals with multiple system atrophy (MSA) diagnosed within the last 5 years, having motor or autonomic symptoms. They should have a UMSARS Part I score ≤16 and a MoCA score ≥22, indicating certain levels of physical and cognitive function. Participants must be likely to follow the study protocol and not have used other investigational products recently.Check my eligibility
What is being tested?
The study tests Lu AF82422's effect on disease progression in MSA patients against a placebo. It aims to understand if this drug can slow down the worsening of symptoms associated with MSA, which includes both parkinsonian (MSA-P) and cerebellar types (MSA-C).See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to Lu AF82422 compared to those receiving a placebo. Side effects could range from mild to severe depending on individual responses.
AMULET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
It seems like there might be some missing information here. Can you provide more details or context for the criterion you'd like me to summarize?
AMULET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, eotdbp (week 48 to 72)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, eotdbp (week 48 to 72)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 48 in the DBP
Change From Baseline in Composite Autonomic Symptom Score Select Change (COMPASS Select Change) Score at Week 48 in the DBP
Change From Baseline in EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Score at Week 48 in the DBP
+14 moreAMULET Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants in the DBP will receive Lu AF82422 matching placebo IV infusion Q4W from Baseline for a minimum 48 weeks up to a maximum 72 weeks.
Group II: Lu AF82422Experimental Treatment1 Intervention
Participants in the DBP will receive Lu AF82422 intravenous (IV) infusion every 4 weeks (Q4W) from Baseline for a minimum 48 weeks up to a maximum 72 weeks. In the optional OLE, all participants will receive Lu AF82422 IV infusion starting on Day 1 of the OLE up to week 44.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AF82422
2018
Completed Phase 1
~80
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,519 Total Patients Enrolled
3 Trials studying Multiple System Atrophy
264 Patients Enrolled for Multiple System Atrophy
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,276 Total Patients Enrolled
1 Trials studying Multiple System Atrophy
90 Patients Enrolled for Multiple System Atrophy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your UMSARS Part I score is less than or equal to 16, excluding the item about sexual function.I have not been treated with specific Parkinson's disease therapies in the last year.I have been diagnosed with a type of multiple system atrophy (MSA).You need to score at least 22 on a test called the Montreal Cognitive Assessment (MoCA) to take part in the study.You started having symptoms of a condition called MSA (multiple system atrophy) within 5 years before the screening visit, according to the doctor.I finished the DBP within the last 5 months and will join the OLE by end of Q1 2024.I have been diagnosed with a movement disorder other than MSA.I have no significant health issues other than MSA.I have never received a vaccine targeting α-synuclein.Two or more of my blood relatives have had MSA.It seems like there might be some missing information here. Can you provide more details or context for the criterion you'd like me to summarize?
Research Study Groups:
This trial has the following groups:- Group 1: Lu AF82422
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the harmful effects that Lu AF82422 has on humans?
"Lu AF82422 is still being clinically tested for both safety and efficacy. To date, there is only data supporting its safety. Our team has given it a score of 2."
Answered by AI
Are there different branches managing this study in various locations?
"University of California, San Diego in La Jolla, Rocky Mountain Movement Disorders Center in Englewood, The Parkinson's and Movement Disorder Institute in Fountain Valley are a few of the 17 active sites for this study."
Answered by AI
Are there any specific inclusionary requirements for this trial?
"This particular clinical trial is seeking 60 individuals with multiple system atrophy that are between 40 and 75 years old. The most crucial element for participants is that they must meet the following requirements: A diagnosis of 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, Motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator, An UMSARS Part I score ≤16 (om"
Answered by AI
Can elderly patients participate in this research?
"To be included in this clinical trial, patients must meet the age requirement of being over 40 but under 75."
Answered by AI
How can somebody sign up for this experiment?
"The clinical trial in question, which was created on November 16th 2021, is not actively recruiting patients. Although this may be the case, there are many other trials (200+) that are still enrolling individuals."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
New York
How old are they?
18 - 65
What site did they apply to?
NYU Medical Center - Dysautonomia center
University of California, San Diego
University of Pennsylvania
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I want to help find treatment or a cure for MSA. I would like to see if this drug will slow progression and provide a better QOL.
PatientReceived 1 prior treatment
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