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Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

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Trial Profile

Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Eslicarbazepine acetate (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Sponsors Sunovion Pharmaceuticals

    • Most Recent Events

    • 01 Jul 2019 Results of post hoc exploratory analysis examining the frequency of hyponatremia in five controlled phase 3 trials of ESL and their open-label extensions (OLEs) (NCT00957684, NCT00957047, NCT00988429, NCT00866775, NCT01091662) published in the Epilepsia
    • 27 Apr 2018 Results of analysis of cognitive adverse events in NCT00866775 and NCT01091662 trials presented at the 70th Annual Meeting of the American Academy of Neurology
    • 27 Apr 2018 Results of analysis of the efficacy and tolerability of Eslicarbazepine Acetate by study period in NCT00866775 and NCT01091662 trials presented at the 70th Annual Meeting of the American Academy of Neurology

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