ClinicalTrials.gg
CompletedNCT05864365Updated Apr 1, 2025

A Biomarker Study of ATH434 in Participants With MSA

A Phase 2 interventional study of ATH434 in Multiple System Atrophy, sponsored by Alterity Therapeutics. Completed at 1 site in United States. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Alterity Therapeutics · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2025, 1 year 8 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
30 Years to 75 Years
Sex
All
01

Study summary

This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy

02

Conditions studied

  • Multiple System Atrophy

Keywords

  • Multiple System Atrophy
  • ATH434
  • Neurodegenerative disease
  • Shy-Drager Syndrome
  • Movement disorders
  • Autonomic dysfunction
  • Synucleinopathies
  • Atypical parkinsonism
  • Biomarkers
03

In context

Multiple System Atrophy

207 studies on the registry are indexed under Multiple System Atrophy; 73 are open to participants now.

This study's enrollment of 10 is below the median of 41 across 134 interventional studies indexed under Multiple System Atrophy.

Browse Multiple System Atrophy studies →

Lead sponsor

Alterity Therapeutics is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant has clinical features of parkinsonism.
  2. Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
  3. Participant has ataxia and/or pyramidal signs on neurological examination.
  4. Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion criteria

Exclusion Criteria:

  1. Participant is unable to swallow study drug.
  2. Participant is unable to attend study visits or complete study procedures.
  3. Participant has structural brain abnormality on MRI.
  4. Participant has any significant neurological disorder other than MSA.
  5. Participant has an unstable medical or psychiatric illness.
  6. Participant has a to, or is unable to tolerate, MRI or lumbar puncture.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    ATH434

    Drug: ATH434

Interventions

  • DrugATH434

    ATH434 taken by mouth two times per day

06

What researchers measure

Primary outcomes

  1. Change in brain volume as measured by MRI

    Time frame: Change from Baseline to Week 52

Secondary outcomes

  1. Change in iron content in substantia nigra as measured by MRI

    Time frame: Change from Baseline to Week 52

  2. Change in Unified MSA Rating Scale (UMSARS) Score

    Time frame: Change from Baseline to Week 52

  3. Change in Patient Global Impression of Change (PGI-C)

    Time frame: Change from Baseline to Week 52

  4. Change in Clinical Global Impression of Change (CGI-C)

    Time frame: Change from Baseline to Week 52

  5. Change in Neurofilament Light Chain Levels

    Time frame: Change from Baseline to Week 52

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05864365
Lead sponsor
Alterity Therapeutics
Responsible party
Sponsor
First posted
May 18, 2023
Start date
May 23, 2023
Primary completion
Feb 26, 2025
Completion
Feb 26, 2025
Last update
Apr 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: ATH434

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