The X-TOLE2 Phase 3 clinical trial is a study to see how well and safely a medicine called XEN1101 works for people with focal-onset seizures. Focal-onset seizures start in one area of the brain. In this study, 360 participants will be randomly split into three groups. Some will get XEN1101, while others will receive a placebo, which is a pill that looks like the real medicine but doesn’t have any medicine in it. The study will last for about 21.5 weeks. First, there will be up to 9.5 weeks to check how often seizures happen, followed by 12 weeks of taking the pills. People who finish this part can join a longer study to keep taking XEN1101 if they want.
- The study lasts about 21.5 weeks, plus 8 more weeks if you don't join the longer study.
- Participants need to be on 1 to 3 stable anti-seizure medicines for at least a month before starting.
- People must have had focal epilepsy for at least 2 years and keep a seizure diary.