NCT05864365

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 23, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1.8 years

First QC Date

May 9, 2023

Last Update Submit

March 26, 2025

Conditions

Multiple System Atrophy

Keywords

Multiple System AtrophyATH434Neurodegenerative diseaseShy-Drager SyndromeMovement disordersAutonomic dysfunctionSynucleinopathiesAtypical parkinsonismBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in brain volume as measured by MRI

    Change from Baseline to Week 52

Secondary Outcomes (5)

  • 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

Study Arms (1)

ATH434

EXPERIMENTAL
Drug: ATH434

Interventions

ATH434DRUG

ATH434 taken by mouth two times per day

ATH434

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Multiple System AtrophyNeurodegenerative DiseasesShy-Drager SyndromeMovement DisordersPrimary DysautonomiasSynucleinopathies

Interventions

ATH434

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesHypotensionVascular DiseasesCardiovascular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

May 23, 2023

Primary Completion

February 26, 2025

Study Completion

February 26, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)