CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Everolimusdrug
Likely dose
Everolimus 5 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01070316
NCT01070316Phase 2Completed
CompareCT.gov

Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex

Children's Hospital Medical Center, Cincinnati·interventional·Posted Feb 18, 2010·Updated Mar 13, 2017

In Brief

A Phase 2 clinical trial evaluating Everolimus for Epilepsy and Tuberous Sclerosis Complex. Completed, enrolled 20 participants across 2 sites.

Detailed Summary

The goal of this study is to learn if the study drug RAD001 can reduced the number of epileptic seizures, and can be taken safety by people who have epilepsy associated with Tuberous Sclerosis Complex.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Tuberous Sclerosis Complex
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 18, 2010
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.4 years ago

Interventions

Everolimusdrug

Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day