Skip to main content
OpenTrials
Completed

NCT Number: NCT05864365

A Biomarker Study of ATH434 in Participants With MSA

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple System Atrophy Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Metabolic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Primary Dysautonomias Proteostasis Deficiencies Shy-Drager Syndrome Synucleinopathies Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Participant is unable to swallow study drug.
  • Participant is unable to attend study visits or complete study procedures.
  • Participant has structural brain abnormality on MRI.
  • Participant has any significant neurological disorder other than MSA.
  • Participant has an unstable medical or psychiatric illness.
  • Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.

Treatment and study plan

ATH434

Drug

ATH434 taken by mouth two times per day

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

Sponsors and collaborators

Lead sponsor

Alterity Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.