Adjunctive Everolimus Treatment of Refractory Epilepsy

This project is a prospective, randomized, placebo-controlled, double-blind study that will evaluate the clinical efficacy of everolimus as an adjunctive treatment in adult patients diagnosed with refractory epilepsy.

Inclusion Criteria:Diagnosis of drug resistant epilepsy, with treatment of at least two approved anti-epileptic drugs (AEDs), and having at least one reported seizure per month during the 3-month baseline phase and no continuous 3-month seizure-free period.Diagnosis of focal epilepsy without secondary generalization.Treatment with a stable dose of AEDs that must have no drug interactions with everolimus (eg, valproic acid, topiramate, oxazepine, phenobarbital, phenytoin, and primidone) for at least 12 weeks before enrollment.Exclusion Criteria:History of non-drug treatment for epilepsy, eg, vagus nerve stimulation (VNS), ketogenic diet, and epilepsy surgery.Severe dysfunction in kidney.With significant infectious, immunologic, or oncologic comorbidity at the time of enrollment.Currently taking or previously treated systemically with an mammilian target of rapamycin (mTOR) inhibitor.History of seizures secondary to drug abuse, psychogenic nonepileptic seizures, or an episode of status epilepticus within 1 year before enrollment.