Adjunctive everolimus therapy for treatment-resistant focal-onset seizures associated with tuberous sclerosis (EXIST-3): a phase 3, randomised, double-blind, placebo-controlled study
Date
2016Author
FRANZ, David N.
Yapici, Zühal
PELOV, Diana
French, Jacqueline A.
Lawson, John A.
Ikeda, Hiroko
Polster, Tilman
Nobbout, Rima
Curatolo, Paolo
de Vries, Petrus J.
Diugos, Dennis J.
Berkowitz, Noah
VOI, Maurizio
PEYRARD, Severine
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Background Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been used for various benign tumours associated with tuberous sclerosis complex. We assessed the efficacy and safety of two trough exposure concentrations of everolimus, 3-7 ng/mL (low exposure) and 9-15 ng/mL (high exposure), compared with placebo as adjunctive therapy for treatment-resistant focal-onset seizures in tuberous sclerosis complex.
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