Adjunctive Everolimus Treatment of Refractory Epilepsy

Epilepsy Clinical Trial

Official title: A Prospective, Randomized, Double-blind, Placebo-Controlled Phase Ⅱ Study to Evaluate the Efficacy of Adjunctive Everolimus Treatment in Patients With Refractory Epilepsy

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

• NCT number: NCT05613166
• Study type: Interventional
• Source: National Institute on Drug Dependence, China
• Contact: Weining Ma, MD.
• Phone: 86-024-96615-36316
• Email: maweining1985@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2022
• Completion date: March 2023