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CompletedNCT05109091Updated Dec 13, 2024

Study of ATH434 in Participants with Multiple System Atrophy

A Phase 2 interventional study of ATH434 dose level 1 and ATH434 dose level 2 in Multiple System Atrophy, sponsored by Alterity Therapeutics. Completed at 23 sites in 6 countries. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-13.

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

From the registry’s dates

  • Primary completion was Nov 2024, 1 year 11 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

This study will assess the safety and efficacy of ATH434 in participants with 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
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 77 is above 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 is ambulatory.
  5. Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion criteria

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 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
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    ATH434 Arm 1

    Drug: ATH434 dose level 1

  • Experimental
    ATH434 Arm 2

    Drug: ATH434 dose level 2

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

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

07

Study locations

23 sites
  • University of California San Diego
    La Jolla, California 92093, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
  • The Movement Disorder Clinic of Oklahoma
    Tulsa, Oklahoma 74136, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • St Vincent's Hospital (Sydney)
    Darlinghurst, New South Wales, Australia
  • Westmead Hospital
    Westmead, New South Wales, Australia
  • The Alfred Hospital
    Melbourne, Victoria, Australia
  • CHU de Toulouse/Hôpital Pierre-Paul Riquet
    Toulouse, Haute-Garonne 31059, France
  • CHU/HU Pitié Salpêtrière
    Paris, Ile-de-France 75013, France
  • CHU de Bordeaux/Groupe Hospitalier Pellegrin
    Bordeaux, 33076, France
  • CHU de Marseille/Hôpital de la Timone
    Marseille, 13005, France
  • IRCCS Istituto Delle Scienze Neurologiche di Bologna
    Bologna, Italy
  • Policlinico di Milano
    Milan, Italy
  • Azienda Ospedaliero-Universitaria Pisana
    Pisa, Italy
  • AOU San Giovanni di Dio Ruggi d'Aragona
    Salerno, Italy
  • New Zealand Brain Research Institute
    Christchurch, New Zealand
  • Auckland City Hospital
    Grafton, New Zealand
  • University College London
    London, England, United Kingdom
  • Newcastle University
    Newcastle Upon Tyne, England, United Kingdom
  • Salford Royal Hospital
    Salford, England, United Kingdom
  • Queen Elizabeth University Hospital
    Glasgow, Scotland, United Kingdom
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 Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05109091
Lead sponsor
Alterity Therapeutics
Responsible party
Sponsor
First posted
Nov 5, 2021
Start date
Jul 1, 2022
Primary completion
Nov 28, 2024
Completion
Nov 28, 2024
Last update
Dec 13, 2024

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 Dec 2024. 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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