Biomarker Study of ATH434 in Participants With MSA

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ATH434

About this trial

This is an interventional treatment trial for Multiple System Atrophy focused on measuring Multiple System Atrophy, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Synucleinopathies, Atypical parkinsonism, Biomarkers

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ATH434

Arm Description

Outcomes

Primary Outcome Measures

Change in iron content as measured by brain MRI

Secondary Outcome Measures

Change in Aggregating alpha-Synuclein Levels

Change in Neurofilament Light Chain Levels

Change in Unified MSA Rating Scale (UMSARS) Score

Change in 36-Item Short Form Survey (SF-36) Score

Full Information

NCT ID

NCT05864365

First Posted

May 9, 2023

Last Updated

June 18, 2023

Sponsor

Alterity Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05864365

Brief Title

Biomarker Study of ATH434 in Participants With MSA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 23, 2023 (Actual)

Primary Completion Date

December 15, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alterity Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple System Atrophy

Keywords

Multiple System Atrophy, ATH434, Neurodegenerative disease, Shy-Drager Syndrome, Movement disorders, Autonomic dysfunction, Synucleinopathies, Atypical parkinsonism, Biomarkers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ATH434

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ATH434

Intervention Description

ATH434 taken by mouth two times per day

Primary Outcome Measure Information:

Title

Change in iron content as measured by brain MRI

Time Frame