Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What the study measures
- Trial status and size
- Patient glossary of key terms
Trial overview
The available study for 5,7-DICHLORO-2-((ETHYLAMINO)METHYL)-8-HYDROXY-3-METHYLQUINAZOLIN-4(3H)-ONE METHANESULFONATE is an open-label extension study called “Open-Label Extension Study to Provide Access to ATH434 in Patients with Multiple System Atrophy.”[1] It is studying people with multiple system atrophy (MSA).[1]
The brief summary says the study is designed to assess the long-term safety and tolerability of ATH434 in participants with MSA who are receiving open-label treatment.[1]
Who can participate
The source data show that the target population is participants with multiple system atrophy.[1] The study is an extension study, so it is for people already receiving open-label treatment in this setting.[1]
The trial record does not provide more detailed entry rules such as age limits, disease stage, or other eligibility requirements.[1]
Study design and phase
This is an interventional study, which means participants receive a study treatment and researchers observe the results.[1] The study is listed as Phase 2.[1]
It is also open-label, meaning there is no blinding in the source data and participants receive the study drug with researchers aware of the treatment being given.[1] The study is an extension study, which means it continues follow-up after earlier research so that longer-term data can be collected.[1]
The intervention listed in the trial record is ATH434-DP2, given by oral use at 150 mg/g milligram(s)/gram.[1]
What the study measures
The primary outcome is long-term safety and tolerability.[1] Safety means whether harmful medical problems happen, and tolerability means whether people can continue treatment without too much trouble.
Researchers are measuring the incidence and severity of adverse events and serious adverse events.[1] An adverse event is any unwanted health problem during a study, while a serious adverse event is a more severe problem.[1]
The study also checks changes in laboratory and vital sign parameters, including orthostatic measures.[1] Orthostatic measures are checks related to what happens when a person stands up, such as changes in blood pressure.[1]
Other measured outcomes include exposure to ATH434, treatment discontinuations due to adverse events, and deaths.[1] These measures help researchers understand how the treatment is used over time and whether people stop it because of side effects.[1]
Trial status and size
The study status is Authorised.[1] The enrollment is 7 participants, so this is a small study.[1]
Because the available trial data describe one authorised Phase 2 study, the article focuses on this single clinical trial rather than a larger trial program.[1]
Patient glossary of key terms
- Authorised: The study has official approval to run, based on the source record.[1]
- Enrollment: The number of participants planned or entered in the study.[1]
- Interventional study: A study where a treatment is given to participants and then studied.[1]
- Open-label extension study: A follow-up study in which everyone knows the treatment and the study continues to collect data over time.[1]
- Laboratory parameters: Test results used to monitor health and safety.[1]
- Vital signs: Basic body measurements such as pulse and blood pressure.[1]
