The Safety and Efficacy Evaluation of Sirolomus as an Adjunctive Treatment for Focal Refractory Epilepsy: A Pilot Study
The aim of this study is to evaluate the clinical efficacy of sirolimus as an adjunctive therapy for refractory epilepsy. The significance lies in addressing whether the mTOR inhibitor sirolimus has antiepileptic adjunctive effects for a broader range of patients with refractory epilepsy, with the hope of providing a new mTOR-targeted antiepileptic adjunctive medication regimen that is administered only during epileptic events and can be widely used for various types of refractory epilepsy.
• 18-60 years of age.
• Meet the 2017 International League Against Epilepsy (ILAE) diagnostic criteria for for focal seizures or focal seizures progressing to bilateral tonic-clonic seizures.
• Diagnosed with refractory epilepsy, having used at least two AEDs without effectiveness for 2 years. No drug interaction between current AEDs and sirolomus, and a stable dose for at least 12 weeks prior to enrollment.
• Seizure duration ≥1 minute, with accompanying sensory impairment.
• At least 6 focal seizures within the 12 weeks preceding enrollment.
• EEG or MRI/CT results within the past 2 years, confirming the diagnosis of focal epilepsy.
• The use of vagus nerve stimulation (VNS) and deep brain stimulation (DBS) is permitted, need to implant at least 5 months and stable for at least 12 weeks before enrollment.The parameters should keep unchanged until the end of the study.
• Informed consent signed.