Adjunctive Everolimus (RAD 001) Therapy for Epilepsy in Children With Sturge-Weber Syndrome (SWS)

Inclusion Criteria: * 2-18 years of age, male and female. * Subject weights greater than or equal to 6 kg at study entry. * Subjects clinically diagnosed with SWS, inclusive of cerebral and dermatologic involvement. Ophthalmic involvement will be monitored if present, but is not necessary for enrollment. * History of epilepsy with a history of at least 4 seizures in the month prior to screening. * Medically refractory epilepsy defined as failure of two or more approved antiepileptic therapies. * Females of child-bearing potential must use highly effective contraception during the study and for 8 weeks after stopping treatment. * Sexually active males must use a condom during intercourse while taking study drug, and for 8 weeks after stopping study treatment. * Adequate bone marrow function. * Adequate liver function. * Adequate renal function. * Acceptable fasting serum cholesterol and fasting triglycerides levels. Exclusion Criteria: * Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of Everolimus (including chemotherapy, radiation therapy, antibody based therapy, etc.). * Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs. * Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral Everolimus. * Uncontrolled diabetes mellitus despite adequate therapy. * Patients who have any severe and/or uncontrolled medical condit…