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.
The project consists of a screening and baseline monitoring period of 1-2 weeks, and a treatment period of 1 week, followed by a 3-month follow-up period. Approximately 108 participants will be randomized in a blinded manner to one of three arms in a 1:1:1 fashion (everolimus 1h : everolimus 8-9h : Placebo). After screening, participants will have the first video-EEG monitoring for up to 24 hours to assess baseline levels, followed by 1 week of treatment, the second video-EEG monitoring, and a 3-month post treatment follow-up period. During the treatment period, participants will be given everolimus or placebo directed to seizure events. In the "everolimus 1h" group, everolimus will be administrated immediately after seizure events (within 1 hour); while in the "everolimus 8-9h" group, everolimus administration will be delayed (at 8-9 hours after seizure events). We conduct this study to assess the efficacy of everolimus in adult refractory epilepsy patients under an administration strategy in a limited time window immediately after seizure events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Everolimus will be administrated orally based on seizure events, with an administration interval longer than 24 hours. Participates with a body surface area (BSA) of \<= 1.2 m\^2, the dosage was 2.5 mg/time; for BSA 1.3-2.1 m\^2, the dosage was 5 mg/time; and for BSA \>=2.2 m\^2, the dosage was 7.5 mg/time.
Vitamin C
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGChange from baseline frequency of epileptic discharge
Comparing frequency of epileptic discharge during video-EEG monitoring after versus before treatment
Time frame: 1 week
Change from baseline seizure frequency
Comparing number of seizures in 3 months after treatment versus baseline
Time frame: 6 months
Change from baseline seizure types
Comparing types of seizures in 3 months after treatment versus baseline
Time frame: 6 months
Change from baseline frequency of seizure-free days
Comparing seizure-free days in 3 months after treatment versus baseline
Time frame: 6 months
Seizure-free rate
Patients remaining seizure free in 3 months after treatment
Time frame: 3 months
Change from baseline occurrence of secondary generalized seizure and status epilepticus
Comparing number of occurrence of secondary generalized seizure and status epilepticus in 3 months after treatment versus baseline
Time frame: 6 months
Quality of life questionnaire (QOLIE-31-Chinese version) scores
Comparing the scores at 3 months after treatment versus before treatment
Time frame: 3 months
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