A Multicenter, Postmarketing Observational Study to Evaluate the Safety of Fycompa for Injection in Patients With Partial-Onset or Primary Generalized Tonic-Clonic Seizures

What this Trial Is About

Researchers are evaluating the safety of Fycompa for injection in people with epilepsy who have partial-onset seizures, including secondarily generalized seizures, starting at age 4, and those with primary generalized tonic-clonic seizures starting at age 12. This observational study aims to monitor adverse drug reactions and side effects up to 4 weeks after administration, with a focus on different participant characteristics and plasma drug levels in children aged 4 to under 12 years. This is a non-interventional study where participants receive Fycompa as part of their usual clinical care, without any experimental treatment assigned by the study. The study does not involve additional treatments or placebo groups and observes participants in their normal treatment settings. Participants will be monitored for up to 4 weeks to record any adverse drug reactions and adverse events. Researchers will also measure plasma concentrations of Fycompa in children. The study collects safety data based on real-world use and participant characteristics, with no additional procedures beyond routine clinical practice. The total participation duration is up to 4 weeks after the first Fycompa injection.

A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures