Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France

Sponsor
Alterity Therapeutics
Study ID
NCT07729852
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Multiple System Atrophy

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • ATH434 — DRUG
    ATH434 75 mg tablets administered orally twice daily (BID).

Study Details

This multicenter open-label extension study conducted in France is designed to provide ATH434 orally BID to eligible patients who completed the Phase 2 study ATH434-201, and who may benefit from this treatment according to the evaluation by the Investigator.

Key Dates

First listed
Jul 28, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ATH434 75mg BID
    Participants who completed the prior ATH434-201 Phase 2 trial will receive ATH434 75 mg orally twice daily (BID). Treatment consists of an initial 12-month treatment phase, followed by an ongoing extension phase based on investigator assessment of continued clinical benefit, safety, and tolerability

Primary Outcome Measure

Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to completion of study treatment, an average of 1 year. ]

Central Contacts

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