Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
EpilepsyTuberous Sclerosis Complex
Interventions
DRUG

Everolimus

Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day

Trial Locations (2)

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

77030

Baylor College of Medicine, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Children's Hospital Medical Center, Cincinnati

OTHER