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A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

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Trial Profile

A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2022

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At a glance

  • Drugs Lacosamide (Primary) ; Lacosamide (Primary)
  • Indications Generalised seizures; Tonic-clonic epilepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms VALOR
  • Sponsors UCB Biosciences

    • Most Recent Events

    • 01 Sep 2021 Results of post-hoc subgroup analysis (n=190) assessing efficacy and tolerability of adjunctive lacosamide in patients with primary generalized tonic-clonic seizures (PGTCS) by Baseline PGTCS frequency, presented at the 34th International Epilepsy Congress.
    • 17 Dec 2020 According to an UCB media release, The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for VIMPAT as adjunctive therapy in the treatment of PGTCS in adults, adolescents and children from four years of age with idiopathic generalized epilepsy.6 Regulatory reviews for use of VIMPAT in the treatment of PGTCS are also underway in Japan and Australia.
    • 08 Dec 2020 Results of subgroup analyses of a double-blind, randomized, placebo-controlled trial presented at the 74th Annual Meeting of the American Epilepsy Society
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