Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France (NCT07729852) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Open-Label Access to ATH434 for Patients Who Completed Study ATH434-201 in France
France5 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, Severity, and Relationship of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Baseline to completion of study treatment, an average of 1 year.
2
Change From Baseline in Clinical Laboratory Parameters
Timeframe: Baseline to completion of study treatment, an average of 1 year.
3
Change From Baseline in Vital Signs
Timeframe: Baseline to completion of study treatment, an average of 1 year.
4
Duration of Exposure to ATH434
Timeframe: Baseline to completion of study treatment, an average of 1 year.
5
Cumulative Dose of ATH434
Timeframe: Baseline to completion of study treatment, an average of 1 year.