Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Keppra injection is approved in the US as adjunctive therapy in the treatment of partial
      onset seizures in adults with epilepsy. The objective of the current study is to assess the
      safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4
      years.
    

Detailed description: 
      The primary objective of this study was to evaluate the safety and tolerability of
      levetiracetam intravenous 15-minute infusion administered every 12 hours, either as
      adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy
      (except status epilepticus), either after switching from the equivalent levetiracetam oral
      dose administration or as a new antiepileptic treatment.

      The evaluation period was to be considered as one complete set of 4 pharmacokinetic (PK)
      samples for a maximum of 4 days;

      For children already taking levetiracetam oral solution prior to entering the study, the
      levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose
      (always in twice daily regimen) within the following dose range, calculated on the basis of
      their age and weight:

        -  Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42
           mg/kg/day (i.e 21 mg/kg/day twice daily);

        -  Children ≥ 6 months to < 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60
           mg/kg/day (i.e 30 mg/kg/day twice daily).

      The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose
      of levetiracetam.

      For children not taking levetiracetam oral solution prior to entering the study, the
      intravenous (IV) dose will correspond to their age and weight as follows:

        -  Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily).

        -  Children ≥ 6 months to < 4 years: 20 mg/kg/day (i.e. 10 mg/kg twice daily).

      However, when necessary for the safety of the subject or when the investigator deemed it
      appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.

      Subjects were hospitalized for the duration of the levetiracetam intravenous (LEV IV)
      treatment.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Other intervention name(s): Keppra®; ucb L059
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Child; Levetiracetam; Keppra®; Infusion; Intravenous