ABOUT THE FAiRE LGS STUDY
Lennox-Gastaut syndrome (LGS) is a rare and severe form of epilepsy that is very difficult to treat. Although approved medications for LGS exist, many patients still struggle to manage their seizures and are in need of new and more effective treatment options.
The FAiRE LGS research study is trying to meet this need by determining whether a low-dose of a drug called ZX008 is safe and effective compared to placebo (a look-a-like that contains no active medicine) in controlling seizures that result in falls in children and adults with LGS.
This study will track seizure frequency, measure exposure to the drug, and also evaluate whether the the drug has an impact on other, non-seizure related aspects of the condition, such as overall quality of life.
- Part 1: Participants will receive either ZX008 or placebo. This part will last approximately 20 weeks and include 6 office visits and 6 phone calls.
- Part 2: All participants receive ZX008. This part will last up to 54 weeks and include approximately 7 office visits and 1 phone call.During both parts, participants will be expected to take the study medication twice a day - in addition to their current anti-epileptic treatment(s) - and to complete an electronic diary that documents seizures every day.