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A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or General Tonic-clonic Seizures

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Trial Profile

A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or General Tonic-clonic Seizures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2023

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At a glance

  • Drugs Lacosamide (Primary) ; Carbamazepine
  • Indications Partial epilepsies; Tonic-clonic epilepsy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors UCB

Most Recent Events

  • 01 Nov 2023 Results of Exploratory post hoc analysis evaluating the efficacy and tolerability of lacosamide (LCM) versus controlled release carbamazepine (CBZ-CR) monotherapy in adults with newly diagnosed , published in the Seizure: European Journal of Epilepsy
  • 17 Nov 2020 Results (n=271) of post-hoc analysis assessing serologic data from a randomized monotherapy trial comparing the controlled-release formulation of CBZ with LCM for the treatment of new-onset focal epilepsy, published in the Epilepsia.
  • 12 Nov 2019 Results of post hoc analyses of pooled long term safety and efficacy data from (NCT01465997 and NCT01243177) published in the Epilepsia published in the Epilepsia

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