ClinicalTrials.gov record NCT07729852

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

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

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label extension provides continued access to oral ATH434 (75 mg twice daily with food) for people with Multiple System Atrophy who completed the Phase 2 ATH434-201 study in France. Up to 5 participants will receive an initial 12 months of treatment, with the option to continue longer if the investigator documents ongoing safety, tolerability, and clinical benefit; continued eligibility is re-evaluated every 3 months. Study contacts will be a mix of in-clinic and remote visits for safety monitoring, clinical evaluations, and drug accountability.

What it is studying. The study is monitoring long-term safety, tolerability, and clinical response to ATH434 in people with Multiple System Atrophy who previously completed ATH434-201. It records adverse events (including serious adverse events), changes from baseline in laboratory tests and vital signs, how long participants stay on the drug, and the total cumulative dose received.

What the researchers hope to learn. Scientific goals are to collect longer-term safety and tolerability data for ATH434, document incidence and severity of adverse events, track laboratory and vital-sign changes from baseline, and record treatment duration and cumulative dose.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • ATH434

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take ATH434 tablets 75 mg twice daily with food and receive treatment for a planned 12‑month period. Care involves a mix of in‑clinic and remote visits for safety monitoring and clinical evaluations, including periodic blood tests, vital‑sign checks, and investigational product accountability. After 12 months, treatment may continue based on the investigator's judgment of ongoing benefit, safety, and tolerability; continued eligibility will be re‑evaluated and documented every 3 months.

How the study is structured. This is an open-label (no masking), single-group extension study. Eligible participants from the prior ATH434-201 trial receive ATH434 75 mg orally twice daily with food. Treatment is planned for 12 months initially, with an extension possible based on the investigator's periodic (every 3 months) assessment of safety, tolerability, and continued clinical benefit. Safety monitoring and clinical evaluations occur through scheduled in-clinic and remote visits; the study enrolls up to 5 participants and does not add new participants beyond the prior trial.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 1, 2026
Primary completion
July 2029 (estimated)
Study completion
July 2029 (estimated)
Target enrollment
7 participants (estimated)
Last updated on registry
Oct 9, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Alterity Therapeutics

Participating sites (4)

  • Hôpital Pierre-Paul Riquet

    Toulouse, Midi-Pyrenees, 31300 · France

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, New Aquitaine, 33076 · France

  • Hôpital de la Timone

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005 · France

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, Île-de-France Region, 75013 · France

Terms used on this page · explanations by MedicalUpdates.ai

open-label extension
A continuation study in which participants who completed an earlier study can keep receiving the treatment, usually with everyone knowing what they are given.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
investigational product
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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