Biomarker Study of ATH434 in Participants With MSA

Multiple System Atrophy Clinical Trial

Official title:

An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05864365
• Other study ID #: ATH434-202
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: May 23, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Alterity Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: February 28, 2025
• Est. primary completion date: February 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Shy-Drager Syndrome

Intervention

Drug:
• ATH434
ATH434 taken by mouth two times per day

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Alterity Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in iron content as measured by brain MRI		Change from Baseline to Week 52
Secondary	Change in Aggregating alpha-Synuclein Levels		Change from Baseline to Week 52
Secondary	Change in Neurofilament Light Chain Levels		Change from Baseline to Week 52
Secondary	Change in Unified MSA Rating Scale (UMSARS) Score		Change from Baseline to Week 52
Secondary	Change in 36-Item Short Form Survey (SF-36) Score		Change from Baseline to Week 52