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Study of ATH434 in Participants With Multiple System Atrophy

Sponsor
Alterity Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05109091
Collaborator
(none)
60
Enrollment
3
Locations
3
Arms
24
Anticipated Duration (Months)
20
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: ATH434 dose level 1
  • Drug: ATH434 dose level 2
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study of ATH434 in Multiple System Atrophy
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo taken BID

    Outcome Measures

    Primary Outcome Measures

    1. Change in iron content as measured by brain MRI [Change from Baseline to Week 52]

    Secondary Outcome Measures

    1. Change in Aggregating alpha-Synuclein Levels [Change from Baseline to Week 52]

    2. Change in Neurofilament Light Chain Levels [Change from Baseline to Week 52]

    3. Change in Unified MSA Rating Scale (UMSARS) Score [Change from Baseline to Week 52]

    4. Change in SF-36 Score [Change from Baseline to Week 52]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 78 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participant has clinical features of parkinsonism.

    2. Participant has evidence of autonomic dysfunction.

    3. Participant has at least one supportive clinical feature of MSA.

    4. Participant is ambulatory.

    Exclusion Criteria:

    1. Participant has long duration of motor symptoms.

    2. Participant has advanced disease.

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New Zealand Brain Research Institute Christchurch New Zealand
    2 Auckland City Hospital Grafton New Zealand
    3 Salford Royal Hospital Salford England United Kingdom

    Sponsors and Collaborators

    • Alterity Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alterity Therapeutics
    ClinicalTrials.gov Identifier:
    NCT05109091
    Other Study ID Numbers:
    • ATH434-201
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alterity Therapeutics
    Multiple System Atrophy
    ATH434
    Neurodegenerative disease
    Shy-Drager Syndrome
    Movement disorders
    Autonomic dysfunction
    Synucleinopathies
    Atypical parkinsonism
    Additional relevant MeSH terms:
    Multiple System Atrophy
    Shy-Drager Syndrome
    Atrophy

    Study Results

    No Results Posted as of Aug 25, 2022