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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2021

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At a glance

  • Drugs Everolimus (Primary)
  • Indications Partial epilepsies; Tuberous sclerosis
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms EXIST-3
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 25 Oct 2021 Results (n=244) the long-term efficacy and safety of everolimus from the EXIST-3 study at the end of the postextension phase, published in the Epilepsia
    • 22 Aug 2019 Results published in the Novartis Media Release.
    • 22 Aug 2019 According to an Novartis media release, everolimus was approved in Japan as an adjunctive treatment of for patients aged two years and older for partial-onset seizures associated with tuberous sclerosis complex (TSC). This approval was based on the safety and efficacy data from this EXIST-3 trial.
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