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ATH434 for Multiple System Atrophy
Phase 2
Waitlist Available
Research Sponsored by Alterity Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has ataxia and/or pyramidal signs on neurological examination.
Participant has clinical features of parkinsonism.
Must not have
Participant has advanced disease, as indicated by frequent falls or choking.
Participant has an unstable medical or psychiatric illness.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will test a new drug called ATH434 to see if it is safe and can help people with Multiple System Atrophy by possibly slowing down the disease or reducing symptoms.
Who is the study for?
This trial is for individuals with Multiple System Atrophy (MSA) who can walk and show specific signs of ataxia, parkinsonism, orthostatic hypotension, or bladder issues. They must have MSA biomarkers in their fluids and MRI evidence. Those with motor symptoms over 4 years, other significant neurological disorders, unstable illnesses, MRI or lumbar puncture contraindications, advanced disease with falls/choking, or brain abnormalities on MRI cannot join.
What is being tested?
The study tests the safety and effectiveness of a drug called ATH434 in two different doses compared to a placebo in people with MSA. Participants will be randomly assigned to receive either the drug at one of two dose levels or a placebo to see if there's an improvement in their condition.
What are the potential side effects?
While the specific side effects of ATH434 are not listed here, common types of side effects from drugs like this may include gastrointestinal discomforts such as nausea or diarrhea; potential allergic reactions; fatigue; dizziness due to blood pressure changes; and possibly headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have coordination issues or stiffness and weakness in my limbs.
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I show symptoms similar to Parkinson's disease.
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I experience dizziness when standing up or have bladder control issues.
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My tests show signs of MSA in my body fluids and MRI.
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I can walk on my own.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I often fall or choke due to my advanced disease.
Select...
I do not have any unstable medical or mental health conditions.
Select...
I cannot undergo MRI or lumbar puncture due to health reasons.
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I have had motor symptoms for more than 4 years.
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I have a significant neurological condition, but it's not MSA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ATH434 Arm 2Experimental Treatment1 Intervention
Group II: ATH434 Arm 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple System Atrophy (MSA) treatments often target the underlying pathophysiological mechanisms, such as alpha-synuclein aggregation. Alpha-synuclein aggregation inhibitors, like ATH434, work by preventing the clumping of alpha-synuclein proteins, which is believed to contribute to the neurodegenerative processes in MSA.
This is crucial for MSA patients because reducing alpha-synuclein aggregation can potentially slow disease progression, alleviate symptoms, and improve quality of life. Other treatments may include dopaminergic medications to manage motor symptoms and autonomic agents to address blood pressure and urinary issues, but targeting alpha-synuclein directly addresses a core aspect of the disease pathology.
Investigational drugs in Alzheimer's disease: current progress.Parkinson risk in idiopathic REM sleep behavior disorder: preparing for neuroprotective trials.
Investigational drugs in Alzheimer's disease: current progress.Parkinson risk in idiopathic REM sleep behavior disorder: preparing for neuroprotective trials.
Find a Location
Who is running the clinical trial?
Alterity TherapeuticsLead Sponsor
2 Previous Clinical Trials
25 Total Patients Enrolled
2 Trials studying Multiple System Atrophy
25 Patients Enrolled for Multiple System Atrophy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I often fall or choke due to my advanced disease.I have coordination issues or stiffness and weakness in my limbs.I do not have any unstable medical or mental health conditions.I show symptoms similar to Parkinson's disease.I experience dizziness when standing up or have bladder control issues.My tests show signs of MSA in my body fluids and MRI.I cannot undergo MRI or lumbar puncture due to health reasons.I have had motor symptoms for more than 4 years.I have a significant neurological condition, but it's not MSA.You have a physical abnormality in your brain as seen on an MRI.I can walk on my own.
Research Study Groups:
This trial has the following groups:- Group 1: ATH434 Arm 1
- Group 2: ATH434 Arm 2
- Group 3: 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.
Multiple System Atrophy Patient Testimony for trial: Trial Name: NCT05109091 — Phase 2
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