ClinicalTrials.gov
History of Changes for Study: NCT05864365
Biomarker Study of ATH434 in Participants With MSA
Latest version (submitted February 5, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 9, 2023 None (earliest Version on record)
2 May 30, 2023 Study Status and Contacts/Locations
3 June 18, 2023 Study Status and Contacts/Locations
4 February 5, 2024 Recruitment Status, Study Status and Contacts/Locations
Comparison Format:
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Study NCT05864365
Submitted Date:  May 9, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: ATH434-202
Brief Title: Biomarker Study of ATH434 in Participants With MSA
Official Title: An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2023
Overall Status: Recruiting
Study Start: May 2023
Primary Completion: December 15, 2024 [Anticipated]
Study Completion: December 31, 2024 [Anticipated]
First Submitted: May 9, 2023
First Submitted that
Met QC Criteria:		 May 9, 2023
First Posted: May 18, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 May 9, 2023
Last Update Posted: May 18, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Alterity Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy
Detailed Description:
Open or close this module Conditions
Conditions: Multiple System Atrophy
Keywords: Multiple System Atrophy
ATH434
Neurodegenerative disease
Shy-Drager Syndrome
Movement disorders
Autonomic dysfunction
Synucleinopathies
Atypical parkinsonism
Biomarkers
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 15 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ATH434 Drug: ATH434
ATH434 taken by mouth two times per day
Open or close this module Outcome Measures
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 ]
Open or close this module Eligibility
Minimum Age: 30 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Alterity Clinical Trials
Telephone: +1 650 300-2141
Email: ClinicalTrials@alteritytherapeutics.com
Locations: United States, Tennessee
Vanderbilt University Medical Center
[Recruiting]
Nashville, Tennessee, United States, 37232
Contact:Contact: Jessie Iregui jessica.iregui@vumc.org
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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