PMID- 18343174 OWN - NLM STAT- MEDLINE DCOM- 20090309 LR - 20181201 IS - 1532-2130 (Electronic) IS - 1090-3798 (Linking) VI - 13 IP - 1 DP - 2009 Jan TI - Open-label, long-term safety study of zonisamide administered to children and adolescents with epilepsy. PG - 3-9 LID - 10.1016/j.ejpn.2008.01.004 [doi] AB - BACKGROUND: Zonisamide is licensed in the EU and USA for the adjunctive treatment of partial-onset seizures in adults but there are few data about its use in children. AIMS: To assess the long-term safety and efficacy of zonisamide in children and adolescents. METHODS: Zonisamide-naive patients (n=109, aged 3-15 years, weight >or=12.5 kg) with a clinical diagnosis of epilepsy (>or=4 seizures/month, receiving 1-2 antiepileptic drugs [AEDs] daily) received zonisamide once or twice daily in an open-label trial. The starting dose was 1mg/kg/day, increased by 2 mg/kg/day every 1-2 weeks at the investigator's discretion to an initial maximum of 12 mg/kg/day. The occurrence of adverse events (AEs) was the primary safety measure. Efficacy was measured via the reductions in seizure frequency and via investigator- and carer-rated global assessment ratings. RESULTS: The mean dose received was 8.5 mg/kg/day. Of the 109 children, 52 (48%) completed 15 months' treatment. Treatment-related AEs, mostly mild-to-moderate in severity, were reported by 58 patients. Seven patients discontinued due to treatment-related AEs. Serious AEs (pancreatitis, decreased sweating, and vertigo) were reported by three patients. A significant (p=0.033) median reduction in 'all seizure' frequency of 2.60 seizures per week was observed. Additionally, a significant (p=0.029) median reduction of 1.80 seizures/week in 'complex partial' seizures was reported. Improvements in investigator- and carer-rated global assessments were noted. CONCLUSIONS: Zonisamide treatment was generally well tolerated and was associated with significant reductions in seizure frequency in this pediatric population with a variety of both partial and generalized medically refractory epilepsy syndromes. FAU - Shinnar, Shlomo AU - Shinnar S AD - Departments of Neurology, Pediatrics and Epidemiology and Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY 10467, USA. sshinnar@aol.com FAU - Pellock, John M AU - Pellock JM FAU - Conry, Joan A AU - Conry JA LA - eng PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20080314 PL - England TA - Eur J Paediatr Neurol JT - European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society JID - 9715169 RN - 0 (Anticonvulsants) RN - 0 (Isoxazoles) RN - 459384H98V (Zonisamide) SB - IM MH - Adolescent MH - Anticonvulsants/administration & dosage/adverse effects/therapeutic use MH - Child MH - Child, Preschool MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Drug Tolerance MH - Epilepsies, Partial/drug therapy/physiopathology MH - Epilepsy/*drug therapy/physiopathology MH - Epilepsy, Generalized/drug therapy/physiopathology MH - Female MH - Humans MH - Isoxazoles/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Pancreatitis/chemically induced MH - Seizures/*drug therapy MH - Severity of Illness Index MH - Sweating/drug effects MH - Time Factors MH - Treatment Outcome MH - Vertigo/chemically induced MH - Zonisamide EDAT- 2008/03/18 09:00 MHDA- 2009/03/10 09:00 CRDT- 2008/03/18 09:00 PHST- 2007/06/27 00:00 [received] PHST- 2007/12/19 00:00 [revised] PHST- 2008/01/06 00:00 [accepted] PHST- 2008/03/18 09:00 [pubmed] PHST- 2009/03/10 09:00 [medline] PHST- 2008/03/18 09:00 [entrez] AID - S1090-3798(08)00009-3 [pii] AID - 10.1016/j.ejpn.2008.01.004 [doi] PST - ppublish SO - Eur J Paediatr Neurol. 2009 Jan;13(1):3-9. doi: 10.1016/j.ejpn.2008.01.004. Epub 2008 Mar 14.