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. N01009.

Trial Profile

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. N01009.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2016

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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