What this Trial Is About

Researchers are evaluating the clinical effects of sirolimus as an additional treatment for people with refractory epilepsy who continue to have seizures despite standard therapy. This study is based on findings that the mTOR pathway plays a role in the "epilepsy memory" process, which may cause recurring seizures. The goal is to determine if sirolimus, an mTOR inhibitor, can reduce seizures when given only during seizure events. This pilot study focuses on patients aged 18 to 60 with focal seizures that have not responded to at least two anti-epileptic drugs for at least two years. Participants receive oral sirolimus only during seizure events. The dose depends on body surface area: 0.5 mg for BSA less than 1.2 m², 1 mg for BSA between 1.3 and 2.1 m², and 1.5 mg for BSA greater than 2.2 m². The study monitors short-term and long-term seizure control effects of sirolimus as an adjunctive therapy. Treatment is given during seizure episodes to test its ability to interfere with the reconsolidation of epileptic memory, aiming to reduce future seizures. During the study, participants have their seizure frequency tracked carefully, with assessments every 28 days to measure changes from baseline. The main outcomes include the percent change in seizure frequency and the proportion of patients experiencing at least a 50% reduction in seizures at 3 months and 12 months. Participants undergo EEG or brain imaging evaluations done within the past two years and stable anti-epileptic drug regimens. Safety and adherence are monitored throughout the trial, which also records any adverse reactions to sirolimus.

Sirolomus Adjuvant Treatment of Focal Refractory Epilepsy (SATFRE)