Biomarker Study of ATH434 in Participants With MSA

Phase 2

Active, not recruiting

• Conditions: Multiple System Atrophy
• Interventions: Drug: ATH434

• Registration Number: NCT05864365
• Lead Sponsor: Alterity Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-05-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-01-31
• Study Completion: 2025-02-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATH434	ATH434	-

Primary Outcome Measures

Name	Time	Method
Change in brain volume as measured by MRI	Change from Baseline to Week 52

Secondary Outcome Measures

Name	Time	Method
Change in iron content in substantia nigra as measured by MRI	Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score	Change from Baseline to Week 52
Change in Patient Global Impression of Change (PGI-C)	Change from Baseline to Week 52
Change in Clinical Global Impression of Change (CGI-C)	Change from Baseline to Week 52
Change in Neurofilament Light Chain Levels	Change from Baseline to Week 52

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States