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Levetiracetam in children with refractory epilepsy: a multicenter open label study in Germany

Joachim Opp1, Ingrid Tuxhorn, Theodor May

  • 1Evangelisches Krankenhaus, Department of Neuropediatrics, Oberhausen, Germany.

Seizure
|September 27, 2005
PubMed

Insights

Levetiracetam (LEV) is a well-tolerated add-on treatment for drug-resistant epilepsy in children. While effective for some, neurologically impaired children may experience more side effects and a poorer response.

Area of Science:

  • Pediatric Neurology
  • Clinical Pharmacology
  • Epileptology

Background:

  • Epilepsy affects a significant pediatric population, with many cases being drug-resistant.
  • Refractory epilepsy in children necessitates exploring novel and effective therapeutic options.
  • Levetiracetam (LEV) has emerged as a potential treatment for various seizure types.

Purpose of the Study:

  • To assess the efficacy and tolerability of Levetiracetam (LEV) as an add-on therapy in a large cohort of pediatric patients with drug-resistant epilepsy.
  • To evaluate the real-world effectiveness of LEV in a multicenter, prospective, observational setting.
  • To identify potential predictors of response and adverse events in children treated with LEV.

Main Methods:

  • A prospective, multicenter, observational study involving 285 pediatric patients (mean age 9.9 years) with refractory generalized and focal epilepsy.
  • Patients received Levetiracetam (LEV) as an open-label, add-on treatment.
  • Efficacy was analyzed in 209 patients over at least 12 weeks, comparing seizure frequency to a 2-week baseline; tolerability was monitored throughout.

Main Results:

  • Levetiracetam (LEV) was generally well-tolerated, with mild to moderate side effects in 44.9% of patients, most commonly somnolence and behavioral changes.
  • No serious persistent adverse events were reported; reversible colitis and an apnea syndrome were noted in specific cases.
  • Efficacy analysis showed 6.2% of patients became seizure-free and 18.7% had >50% seizure reduction; 65.1% showed no response, and 17.8% experienced a decrease in treatment effect.

Conclusions:

  • Levetiracetam (LEV) is a well-tolerated antiepileptic drug that can improve seizure control in children with resistant epilepsy.
  • Neurologically handicapped children are at higher risk for neurocognitive side effects and may have a less favorable treatment response to LEV.
  • LEV represents a valuable therapeutic option for pediatric drug-resistant epilepsy, with careful monitoring recommended for vulnerable subgroups.
Abstract

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