Tuberous Sclerosis Complex-associated Refractory Seizures Clinical Trial
Official title:
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
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].
n/a