Skip to main content
OpenTrials
Completed

NCT Number: NCT05109091

Study of ATH434 in Participants with Multiple System Atrophy

This study will assess the safety and efficacy of ATH434 in participants with 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

St Vincent's Hospital (Sydney), Darlinghurst, New South Wales, Australia

Loading trial locations.

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 is ambulatory.
  • Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion criteria

  • Participant has motor symptoms for > 4 years.
  • Participant has advanced disease, as indicated by frequent falls or choking.
  • 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 dose level 1

Drug

ATH434 taken BID

Other names: PBT434

ATH434 dose level 2

Drug

ATH434 taken BID

Other names: PBT434

Placebo

Drug

Placebo taken BID

Primary outcomes

  1. Change in iron content as measured by brain MRI

    Time frame: Change from Baseline to Week 52

Secondary outcomes

  1. Change in Neurofilament Light Chain Levels

    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 SF-36 Score

    Time frame: Change from Baseline to Week 52

Sponsors and collaborators

Lead sponsor

Alterity Therapeutics

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2021
Registry last updated
Dec 13, 2024

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.