A 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 Et tre-ar...

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Reference: EUCTR2011-000860-90

A 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 Et tre-armet, randomiseret, dobbeltblindt, placebo-kontrolleret klinisk forsøg til vurdering af effekt og sikkerhed ved to forskellige doser everolimus som supplerende behandling til patienter med Tuberøs Sklerosekompleks med vanskeligt kontrollerbare partielle anfald

Woman and Man

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Extract

To compare the reduction in frequency of partial-onset seizures on each of two trough ranges of everolimus (3-7 ng/mL and 9-15 ng/mL) versus placebo in patients with TSC who are taking one to three AEDs


Inclusion criteria

  • Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)