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Trial record 1 of 2 for:    ath434
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Biomarker Study of ATH434 in Participants With MSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05864365
Recruitment Status : Enrolling by invitation
First Posted : May 18, 2023
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Alterity Therapeutics

Study Description
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Brief Summary:
This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: ATH434 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy
Actual Study Start Date : May 23, 2023
Estimated Primary Completion Date : February 14, 2025
Estimated Study Completion Date : February 28, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ATH434 Drug: ATH434
ATH434 taken by mouth two times per day


Outcome Measures
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Primary Outcome Measures :
  1. Change in iron content as measured by brain MRI [ Time Frame: Change from Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Change in Aggregating alpha-Synuclein Levels [ Time Frame: Change from Baseline to Week 52 ]
  2. Change in Neurofilament Light Chain Levels [ Time Frame: Change from Baseline to Week 52 ]
  3. Change in Unified MSA Rating Scale (UMSARS) Score [ Time Frame: Change from Baseline to Week 52 ]
  4. Change in 36-Item Short Form Survey (SF-36) Score [ Time Frame: Change from Baseline to Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

  1. Participant is unable to swallow study drug.
  2. Participant is unable to attend study visits or complete study procedures.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05864365


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Alterity Therapeutics
More Information
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Responsible Party: Alterity Therapeutics
ClinicalTrials.gov Identifier: NCT05864365    
Other Study ID Numbers: ATH434-202
First Posted: May 18, 2023    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024

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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
Biomarkers
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
 Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases