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A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age

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A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2022

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At a glance

  • Drugs Levetiracetam (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Sponsors UCB

    • Most Recent Events

    • 22 Sep 2009 Additional trial location (Argentina) identified as reported by ClinicalTrials.gov.
    • 24 Jul 2009 CHMP of the EMEA has issued a positive opinion recommending the European Commision grant marketing approval for levetiracetam as adjunctive treatment, based on data from this trial.
    • 06 Jun 2008 Data from this trial was included in the sNDA submission to the US FDA.

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