NCT07531433

Post-Trial Access to ATH434 for Patients With Multiple System Atrophy

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Alterity Therapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Detailed description

This multicenter PTA program is designed to provide ATH434 orally BID to eligible patients who have completed the ATH434-201 or ATH434-202 Phase 2 clinical trials, and who may benefit from this treatment according to evaluation by their treating physician. Up to 20 patients will be enrolled in the US. For each patient, treating physicians will request participation in the PTA study and initial ATH434 shipment for patients who meet entry criteria. Upon review and approval by the Medical Monitor/Sponsor, treating physicians will obtain informed consent from the patient and proceed with ATH434 initiation under the PTA program. Pertinent documented medical information will be requested to confirm eligibility and assess patient safety throughout the PTA program. Eligible patients will receive ATH434 tablets BID to be taken with food for up to 12 months, and will complete in-clinic and remote visits for safety and to dispense/return ATH434.

Conditions

• Multiple System Atrophy

Interventions

Type	Name	Description
DRUG	ATH434	ATH434 tablets

Timeline

• First posted: 2026-04-15
• Last updated: 2026-04-15