CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 366 enrolled
Drug / intervention
RAD001 +3 moredrug
Likely dose
RAD001 2 mgfrom 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/NCT01713946
NCT01713946Phase 3Completed
CompareCT.gov

A Three-arm, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Two Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) Who Have Refractory Partial-onset Seizures

Novartis Pharmaceuticals·interventional·Posted Oct 25, 2012·Updated Nov 7, 2018

In Brief

A Phase 3 clinical trial evaluating RAD001, Placebo, and 2 other interventions for Tuberous Sclerosis Complex-associated Refractory Seizures. Completed, enrolled 366 participants across 104 sites in 25 countries.

Detailed Summary

This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:\[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)\], Core phase \[from randomization at Week 0 (V2) to Week 18 (V11)\], Extension phase \[from Week 18 (V11) until 48 weeks after the last patient had completed the core phase\] and Post Extension phase \[from end of Extension phase to end of study\].

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis Complex-associated Refractory Seizures
CountriesArgentina, Australia, Belgium, Canada, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2012
Enrollment StartApr 29, 2013
Primary CompletionOct 25, 2017
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.7 years ago

Interventions

RAD001drug

Everolimus tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister packs and placed in boxes with color-coded labels, color 1 or color 2.

Placebodrug

Placebo tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister packs and placed in boxes with color-coded labels, color 1 or color 2.

Antiepileptic drug (1 to 3 only)drug

no more than any 3 of the listed antiepileptic drugs could be taken with the study drug or placebo. List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin

open label RAD001 (only used for post-extension phase)drug

everolimus tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister backs in boxes with open label design and were taken during the Post-Extension phase, where all the participants, including those who were previously on placebo, took the 2mg tablets.