A Biomarker Study of ATH434 in Participants With MSA

March 26, 2025 updated by: Alterity Therapeutics

An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  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 contraindication to, or is unable to tolerate, MRI or lumbar puncture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATH434
Drug: ATH434
ATH434 taken by mouth two times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in brain volume as measured by MRI
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Neurofilament Light Chain Levels
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52
Change in iron content in substantia nigra as measured by MRI
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52
Change in Patient Global Impression of Change (PGI-C)
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52
Change in Clinical Global Impression of Change (CGI-C)
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alterity Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Actual)

February 26, 2025

Study Completion (Actual)

February 26, 2025

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATH434-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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