Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What is measured in the study
- Key patient terms
Trial overview
The available study is an open-label extension study designed to provide access to ATH434 in patients with multiple system atrophy (MSA).[1]
The trial is authorised, which means it has been approved to run.[1]
The study is interventional, so participants receive a study treatment and the research team follows what happens over time.[1]
Who can participate
The target population is people with MSA.[1]
The enrollment is 7, so this is a very small study group.[1]
The trial summary says it is for participants with MSA who are receiving open-label treatment in this extension study.[1]
Study design and phase
This is a Phase 2 trial.[1]
Phase 2 studies usually look more closely at safety and early signs of benefit in a specific patient group, and here the main focus is long-term follow-up.[1]
The intervention listed is ATH434-DP2, given by oral use at 150 mg/g milligram(s)/gram.[1]
What is measured in the study
The main endpoint is long-term safety and tolerability.[1]
The study checks the incidence and severity of adverse events and serious adverse events.[1]
It also follows changes in laboratory and vital sign results, including orthostatic measures, which are checks done when a person changes position, such as standing up.[1]
Other outcomes include exposure to ATH434, treatment discontinuations due to adverse events, and deaths.[1]
Key patient terms
Open-label means everyone in the study knows which treatment is being used.[1]
Extension study means the research continues after a main study, often to collect more long-term information.[1]
Adverse event means any unwanted medical problem that happens during a study.[1]
Serious adverse event means a major medical problem, such as one that is life-threatening or needs hospital care.[1]
