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An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Trial Profile

An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 May 2024

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At a glance

  • Drugs Cenobamate (Primary)
  • Indications Partial epilepsies; Seizures; Tonic-clonic epilepsy
  • Focus Adverse reactions; Registrational
  • Sponsors SK Life Science
  • Most Recent Events

    • 17 Apr 2024 All the primary end-points are replaced by "Summary of Treatment-Emergent Adverse Events" as the only primary safety end-point, thus removing PK as a trial focus.
    • 27 Jul 2023 Results (n=240) of post-hoc analysis describing sustainability of seizure reduction and seizure control with adjunctive cenobamate ,published in Epilepsia.
    • 29 Jun 2023 According to an Endo International media release, XCOPRI™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy received approval from Health Canada.

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