NCT03198949View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 24, 2018

Primary Completion Date

September 11, 2020

Study Completion Date

September 11, 2020

Conditions
Epilepsy and Focal Cortical Dysplasia II
Interventions
DRUG

Afinitor (everolimus)

"Everolimus doses will be 4.5mg/m2 po daily given at first time and then during the 4-week titration period everolimus dose may get adjusted to reach trough concentration of 5 - 15 ng/mL.~(In order to keep the blind, placebo doses will be also adjusted during core phase based on a random scheme of dose changes.)"

Trial Locations (1)

Unknown

Yonsei University Healthcare System, Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT03198949 - A Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II) | Biotech Hunter | Biotech Hunter