NCT07531433

Brief Summary

This multicenter post-trial access program is designed to provide ATH434 orally BID to eligible patients who completed Phase 2 studies ATH434-201 or ATH434-202, and who may benefit from this treatment according to the evaluation by their treating physicians.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

March 1, 2026

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Interventions

ATH434DRUG

ATH434 tablets

Also known as: PBT434

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Completed Alterity protocol ATH434-201 or ATH434-202
  • Expected to benefit from treatment from treatment with ATH434, in the opinion of the treating physician

You may not qualify if:

  • Discontinued prior ATH434 treatment (ATH434-201 or ATH434-202) for any reason
  • Significant medical or psychiatric condition that may decrease the benefit-risk ratio of participation in this program to an unacceptable level, as per the treating physician's opinion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple System Atrophy

Interventions

ATH4348-hydroxyquinazolin-4(3H)-one

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Alterity Clinical Trials

CONTACT

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Last Updated

April 15, 2026

Record last verified: 2026-03