Study: NCT01713946

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RAD001
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: RAD001
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antiepileptic drug (1 to 3 only)
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Antiepileptic drug (1 to 3 only)
Description: 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

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Antiepileptic drug (1 to 3 only)
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: open label RAD001 (only used for post-extension phase)
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: open label RAD001 (only used for post-extension phase)
Description: 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.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: open label RAD001 (only used for post-extension phase)
Description: 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.