A Biomarker Study of ATH434 in Participants With MSA

NCT ID: NCT05864365

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-23

Study Completion Date

2025-02-26

Brief Summary

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

Detailed Description

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Conditions

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Multiple System Atrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ATH434

Group Type EXPERIMENTAL

ATH434

Intervention Type DRUG

ATH434 taken by mouth two times per day

Interventions

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ATH434

ATH434 taken by mouth two times per day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alterity Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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ATH434-202

Identifier Type: -

Identifier Source: org_study_id

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