A Biomarker Study of ATH434 in Participants With MSA | NCT05864365

Studies
A Biomarker Study of ATH434 in Participants With MSA

NCT05864365

Sponsor

Alterity Therapeutics

Status

Completed

Last Update Posted

Apr 1, 2025Actual

Enrollment

10Actual

Phase

Phase 2

Conditions

Multiple System Atrophy

Interventions

ATH434

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2023Actual

Primary Completion Date

Feb 26, 2025Actual

Completion Date

Feb 26, 2025Actual

First Submitted Date

May 9, 2023

First Submission Date that Met QC Criteria

May 9, 2023

First Posted Date

May 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Apr 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ATH434	Experimental		Drug: ATH434

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATH434	Drug	ATH434 taken by mouth two times per day	ATH434

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in brain volume as measured by MRI		Change from Baseline to Week 52

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has clinical features of parkinsonism.
Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
Participant has ataxia and/or pyramidal signs on neurological examination.
Participant has biomarker evidence of MSA in biologic fluid and on MRI.

Exclusion Criteria:

Participant is unable to swallow study drug.
Participant is unable to attend study visits or complete study procedures.
Participant has structural brain abnormality on MRI.
Participant has any significant neurological disorder other than MSA.
Participant has an unstable medical or psychiatric illness.
Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019578	Multiple System Atrophy
D019636	Neurodegenerative Diseases
D012791	Shy-Drager Syndrome
D009069	Movement Disorders
D054969	Primary Dysautonomias
D000080874	Synucleinopathies

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D001480	Basal Ganglia Diseases
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000723851	ATH434

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided