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NCT Number: NCT07729852

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

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.

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Key information

Conditions

Multiple System Atrophy Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Primary Dysautonomias Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Pierre-Paul Riquet, Toulouse, Midi-Pyrenees, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATH434

Drug

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

Other names: PBT434

Primary outcomes

  1. 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.

    All AEs will be reviewed at every participant contact and documented in the CRF. All SAEs will be reported within 24 hours of awareness in accordance with local regulatory requirements.

  2. Change From Baseline in Clinical Laboratory Parameters

    Time frame: Baseline to completion of study treatment, an average of 1 year.

    Clinical laboratory parameters include hematology and blood chemistry panels.

  3. Change From Baseline in Vital Signs

    Time frame: Baseline to completion of study treatment, an average of 1 year.

    Vital signs include blood pressure, pulse, temperature, and respiration rate.

  4. Duration of Exposure to ATH434

    Time frame: Baseline to completion of study treatment, an average of 1 year.

    Total duration of treatment with investigational product per participant.

  5. Cumulative Dose of ATH434

    Time frame: Baseline to completion of study treatment, an average of 1 year.

    Total cumulative dose of investigational product administered per participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Alterity Clinical Trials

CONTACT

[email protected]

+1 888-556-7582

Sponsors and collaborators

Lead sponsor

Alterity Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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