Long-term use of zonisamide in refractory childhood-onset epilepsy.

This open label study examined the long-term efficacy and safety of zonisamide as adjunctive therapy in mentally retarded and multiple-handicapped patients with severe childhood-onset epilepsy. The study included 24 patients (mean age 12.5 years, range 2-40 years) which had different severe epilepsy syndromes (75% focal, 12.5% generalized, 12.5% refractory status epilepticus) refractory to at least 6 (median 10) anti-epileptic drugs. All patients were followed for at least 18 months after beginning of zonisamide treatment. Mean duration of zonisamide therapy was 55 weeks (range 5-168 weeks) and mean maintenance dosage was 7.7 mg/kg/day (range: 4-16 mg/kg/day). The patients received an average of 1.9 (range 1-3) concomitant antiepileptic drugs. The initial response rate defined as a > or =50% reduction of seizure frequency after 8 weeks was 58.3% (14 of 24 patients). Four of 14 initial responders developed loss of efficacy during long-term treatment. The retention rate after 18 months was 41.7% (10 of 24 patients). One patient (4.2%) became completely seizure-free after initiation of zonisamide treatment and remained seizure-free for the entire observation period of 18 months. Overall, zonisamide was well tolerated. Side effects were observed in 46% of patients and were mild to moderate. They mostly occurred during titration and subsided in maintenance dosing. Only in two patients (8.3%) zonisamide therapy was discontinued due to side effects (loss of appetite). No serious side effects were observed. These results are similar to the findings of Japanese studies suggesting that long-term use of adjunctive zonisamide therapy may be beneficial for treating mentally retarded, multiple handicapped patients with highly refractory childhood-onset epilepsy.
AuthorsGerhard Kluger, Andrea Zsoter, Hans Holthausen
JournalEuropean journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society (Eur J Paediatr Neurol) Vol. 12 Issue 1 Pg. 19-23 (Jan 2008) ISSN: 1090-3798 [Print] England
PMID17574461 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article)
Chemical References
  • Anticonvulsants
  • Isoxazoles
  • zonisamide
  • Adolescent
  • Adult
  • Anticonvulsants (administration & dosage)
  • Child
  • Child, Preschool
  • Drug Administration Schedule
  • Drug Evaluation
  • Electroencephalography
  • Female
  • Humans
  • Isoxazoles (administration & dosage)
  • Male
  • Myoclonic Epilepsy, Juvenile (drug therapy, physiopathology)
  • Retrospective Studies
  • Time

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