Study of ATH434 in Participants With Multiple System Atrophy

September 12, 2023 updated by: Alterity Therapeutics

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • Recruiting
        • St Vincent's Hospital (Sydney)
      • Westmead, New South Wales, Australia
        • Recruiting
        • Westmead Hospital
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • The Alfred Hospital
  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria
        • Recruiting
        • Medizinische Universität Innsbruck
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • CHU de Bordeaux/Groupe Hospitalier Pellegrin
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU de Toulouse/Hôpital Pierre-Paul Riquet
    • Ile-de-France
      • Paris, Ile-de-France, France, 75013
        • Recruiting
        • CHU/HU Pitié Salpêtrière
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • CHU de Lille/Hôpital Roger Salengro
    • Provence Alpes-Côte d'Azur
      • Marseille, Provence Alpes-Côte d'Azur, France, 13005
        • Recruiting
        • CHU de Marseille/Hôpital de la Timone
  • Italy
      • Bologna, Italy
        • Recruiting
        • IRCCS Istituto delle Scienze Neurologiche di Bologna
      • Milan, Italy
        • Recruiting
        • Policlinico di Milano
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Pisana
      • Salerno, Italy
        • Recruiting
        • AOU San Giovanni di Dio Ruggi d'Aragona
  • New Zealand
      • Christchurch, New Zealand
        • Recruiting
        • New Zealand Brain Research Institute
      • Grafton, New Zealand
        • Recruiting
        • Auckland City Hospital
  • United Kingdom
    • England
      • London, England, United Kingdom
        • Recruiting
        • University College London
      • Newcastle Upon Tyne, England, United Kingdom
        • Recruiting
        • Newcastle University
      • Salford, England, United Kingdom
        • Recruiting
        • Salford Royal Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom
        • Recruiting
        • Queen Elizabeth University Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego
    • Florida
      • Gainesville, Florida, United States, 32038
        • Recruiting
        • University of Florida
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
      • Glenview, Illinois, United States, 60201
        • Recruiting
        • NorthShore Medical Group - Glenview
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • The Movement Disorder Clinic of Oklahoma
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • 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

30 years to 75 years (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 is ambulatory.
  5. Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

  1. Participant has motor symptoms for > 4 years.
  2. Participant has advanced disease, as indicated by frequent falls or choking.
  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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo taken BID
Experimental: ATH434 Arm 1
Drug: ATH434 dose level 1
ATH434 taken BID
Other Names:
  • PBT434
Experimental: ATH434 Arm 2
Drug: ATH434 dose level 2
ATH434 taken BID
Other Names:
  • PBT434

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Aggregating alpha-Synuclein Levels
Time Frame: Change from Baseline to Week 52
Change from Baseline to Week 52
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 SF-36 Score
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)

July 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATH434-201

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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