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Not yet recruiting NCT07729852

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

Phase II Interventional Multiple System Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ATH434.
Who it may be relevant to
Registry conditions: Multiple System Atrophy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Open-Label Extension Study to Provide Access to ATH434 in Patients With Multiple System Atrophy

Overview

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.

Detailed description

This is a multicenter, open-label extension (OLE) study designed to provide continued access to the investigational product ATH434 for eligible participants with Multiple System Atrophy (MSA) who have successfully completed the prior Phase 2 clinical trial (ATH434-201) in France. Up to 5 participants will be enrolled. No new participants will be recruited or enrolled in this study.

The primary objective is to monitor long-term safety, tolerability, and clinical response. Eligible participants will receive ATH434 at a dose of 75 mg twice daily (BID) to be taken with food.

The study is divided into two operational phases:

Initial Treatment Phase: Participants will receive treatment for a planned duration of 12 months.

Extension Phase: Participants may continue treatment beyond the initial 12 months based on the investigator's clinical judgment of ongoing benefit, safety, and tolerability. Continued eligibility will be re-evaluated and documented every 3 months.

Participants will undergo a combination of in-clinic and remote visits to perform safety monitoring, clinical evaluations, and investigational product accountability.

Interventions

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

Primary outcome measures

  • 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.]
  • Change From Baseline in Clinical Laboratory Parameters [Time frame: Baseline to completion of study treatment, an average of 1 year.]
  • Change From Baseline in Vital Signs [Time frame: Baseline to completion of study treatment, an average of 1 year.]
  • Duration of Exposure to ATH434 [Time frame: Baseline to completion of study treatment, an average of 1 year.]
  • Cumulative Dose of ATH434 [Time frame: Baseline to completion of study treatment, an average of 1 year.]

Eligibility criteria

Inclusion criteria

  • Completed Alterity protocol ATH434-201.
  • Expected to benefit from treatment from treatment with ATH434, in the opinion of the Investigator.

Exclusion criteria

  • Discontinued prior ATH434 treatment (ATH434-201) 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 Investigator's opinion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 4 centers
  • Hôpital Pierre-Paul Riquet — Toulouse
  • Centre Hospitalier Universitaire de Bordeaux — Bordeaux
  • Hôpital de la Timone — Marseille
  • Hôpital Universitaire Pitié Salpêtrière — Paris

Identifiers

NCT: NCT07729852 · ATH434-203 · 2025-524317-88-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗