[Effects of Long-Term Treatment with Levetiracetam as an Adjunctive Therapy in Japanese Children with Uncontrolled Partial-Onset Seizures: A Multicenter, Open-Label Study]

Brain Nerve. 2015 Nov;67(11):1435-42. doi: 10.11477/mf.1416200317.
[Article in Japanese]

Abstract

Following the first period of the multicenter, open-label, single-armed N01223 trial, the second period of the N01223 trial was conducted to evaluate long-term safety, along with the efficacy of adjunctive levetiracetam treatment (individualized dose range, 20-60 mg/kg/day or 1,000-3,000 mg/day) in Japanese pediatric patients with uncontrolled partial-onset seizures (POS). Of the 62 children who completed the first period, 55 children [age: 10.4 ± 3.4 years (mean ± standard deviation)] were elected to enter the second period for a maximum of 39 months. Twenty children were withdrawn during this second period. Frequencies of treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) were 98.2% (54/55 cases) and 27.3% (15/55 cases), respectively. The most common TEAEs were nasopharyngitis (76.4%), influenza (36.4%) and pyrexia (25.5%). The only frequent ADR (>2%) was somnolence (3.6%). Although serious TEAEs and death were reported in 8 cases and 1 case (drowning), respectively, a serious ADR was only reported in 1 case (vomiting). The median percentage reduction and 50% response rate for POS were 43.32% and 41.8%, respectively. One child showed a maximum seizure-free period of 163 days. In conclusion, levetiracetam demonstrated long-term safety and good tolerance with beneficial efficacy as an adjunctive therapy in Japanese children with uncontrolled POS. (Received June 30, 2015; Accepted July 14, 2015: Published November 1, 2015).

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adolescent
  • Anticonvulsants / administration & dosage
  • Anticonvulsants / therapeutic use*
  • Asian People
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination / methods
  • Epilepsies, Partial / drug therapy*
  • Female
  • Humans
  • Levetiracetam
  • Male
  • Piracetam / administration & dosage
  • Piracetam / analogs & derivatives*
  • Piracetam / therapeutic use
  • Seizures / drug therapy*
  • Time
  • Treatment Outcome

Substances

  • Anticonvulsants
  • Levetiracetam
  • Piracetam