A Phase 2 interventional study of Everolimus and Placebo in Epilepsy, sponsored by National Institute on Drug Dependence, China. Status unknown at 1 site in China. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by National Institute on Drug Dependence, China · Phase 2, Interventional, and Treatment
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.
1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 108 is above the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →National Institute on Drug Dependence, China is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study participants will orally receive everolimus within 1 hour and placebo at 8-9 hours after each seizure event, but with intervals longer than 24 hours.
Drug: Everolimus · Drug: Placebo
The study participants will orally receive placebo within 1 hour and everolimus at 8-9 hours after each seizure event, but with intervals longer than 24 hours.
Drug: Everolimus · Drug: Placebo
The study participants will orally receive placebo both within 1 hour and at 8-9 hours after each seizure event, but with intervals longer than 24 hours.
Drug: Placebo
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.
Also known as: Afinitor
Vitamin C
Change 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
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Dependence, China