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Unknown

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to week 52
Awards & highlights

Study Summary

This trialwill test if a new drug, ATH434, is safe and effective for treating Multiple System Atrophy.

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.Check my eligibility
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.See study design
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 below
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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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My tests show MSA markers in my body fluids and on my MRI.
Select...
I have coordination issues or muscle weakness.
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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.
Select...
I can walk on my own.
Select...
I show symptoms similar to Parkinson's disease.
Select...
I experience sudden drops in blood pressure when standing or have bladder issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in iron content as measured by brain MRI
Secondary outcome measures
Change in Aggregating alpha-Synuclein Levels
Change in Neurofilament Light Chain Levels
Change in SF-36 Score
+1 more

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

Find a Location

Who is running the clinical trial?

Alterity TherapeuticsLead Sponsor
2 Previous Clinical Trials
30 Total Patients Enrolled
2 Trials studying Multiple System Atrophy
30 Patients Enrolled for Multiple System Atrophy

Media Library

ATH434 dose level 1 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05109091 — Phase 2
Multiple System Atrophy Research Study Groups: ATH434 Arm 1, ATH434 Arm 2, Placebo
Multiple System Atrophy Clinical Trial 2023: ATH434 dose level 1 Highlights & Side Effects. Trial Name: NCT05109091 — Phase 2
ATH434 dose level 1 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05109091 — Phase 2
Multiple System Atrophy Patient Testimony for trial: Trial Name: NCT05109091 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for participants in this investigation?

"The latest records on clinicaltrials.gov indicate that this trial is still in its recruitment phase, having been initially listed on July 1st 2022 and last updated January 10th 2023."

Answered by AI

Does this trial extend eligibility to elderly individuals?

"This study is only open to patients aged 30-75 and does not provide such opportunities for those under 18 or over 65. However, 45 studies are available for minors and 148 projects are accessible to seniors."

Answered by AI

Has the ATH434 Arm 1 treatment been approved by the Food and Drug Administration?

"Based on the available data, ATH434 Arm 1 is believed to possess a degree of safety rated at 2. This assessment was made due to this being a Phase 2 trial with some evidence that suggests its security but no proof of efficacy."

Answered by AI

What is the current capacity of this experiment in terms of participant numbers?

"Affirmative. The clinical trial database on clinicialtrials.gov reveals that this research is currently recruiting participants, having been first posted on July 1st 2022 and updated as recently as January 10th 2023. 60 patients are being sought after from a single location to partake in the study."

Answered by AI

What qualifications must individuals meet to participate in this investigation?

"This clinical study is recruiting 60 patients between the ages of 30 and 75 who have been diagnosed with multiple system atrophy. In order to be eligible, participants need to display parkinsonian features, orthostatic hypotension or bladder dysfunction as well as evidence of ataxia and/or pyramidal signs upon neurological examination; they must also retain their ambulatory capabilities while displaying biomarkers indicative of MSA in both biologic fluid samples and MRI scans."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Vanderbilt University Medical Center
University of California San Diego
The Movement Disorder Clinic of Oklahoma
Other

What questions have other patients asked about this trial?

When will you start contacting people for the trail?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I was trying to get involved in a clinical trial. I have MSA and would like to see if this drug will help in any way rather it helps me and/or learn for others.
PatientReceived 2+ prior treatments
~19 spots leftby Nov 2024