Study of ATH434 in Participants with Multiple System Atrophy

Phase 2CompletedNCT05109091

Alterity Therapeutics77 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple System Atrophy

Interventions

ATH434 dose level 1DRUG

ATH434 taken BID

ATH434 dose level 2DRUG

ATH434 taken BID

PlaceboDRUG

Placebo taken BID

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 is ambulatory. 5. Participant has biomarker evidence of MSA in biologic fluid and on MRI. Exclusion Criteria: 1. Participant has motor symptoms for \> 4 years. 2. Participant has advanced disease, as indicated by frequent falls or choking. 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.

Locations (23)

University of California San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

Change in iron content as measured by brain MRI

Time frame: Change from Baseline to Week 52

Secondary Outcomes

Change in Neurofilament Light Chain Levels

Time frame: Change from Baseline to Week 52

Change in Unified MSA Rating Scale (UMSARS) Score

Time frame: Change from Baseline to Week 52

Change in SF-36 Score

Time frame: Change from Baseline to Week 52

Data from ClinicalTrials.gov

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