A Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II)

Summary

This is a prospective, randomized, double-blind, placebo-controlled cross over study designed to evaluate the efficacy and safety of everolimus (trough 5-15 ng/mL) given as adjunctive therapy in patients with focal cortical dysplasia type II who already failed more than two antiepileptic drugs and surgery. This study will assess the impact of everolimus to placebo on seizure frequency in focal cortical dysplasia type II. The number of patients who experience seizure reduction of 50% or more will be counted during last 4 weeks of each core phase.

Timeline

Start

2018-05-24

Primary completion

2020-09-11

Completion

2020-09-11

Outcome

Missed primary endpoint

paper There was no significant difference in the primary outcome between everolimus and placebo groups (24% vs. 19%, p = 0.66). PMID 39607729 ↗

Publications

• Kim SH, Kang HC, Roh YH, Hahn J, Min KL, Lee SJ, Yang D, Choi HS, Park S, Lee JH, Lee SG, Kim SH, Chang MJ, Kim HD. Efficacy and safety of everolimus for patients with focal cortical dysplasia type 2. Epilepsia Open. 2025 Feb;10(1):243-257. doi: 10.1002/epi4.13104. Epub 2024 Nov 28.

Drugs

Indications