Add-on levetiracetam in children and adolescents with refractory epilepsy: results of an open-label multi-centre study.
OBJECTIVE
To study the efficacy and tolerability of add-on levetiracetam in children and adolescents with refractory epilepsy.


METHODS
In this prospective multi-centre, open-label, add-on study, 33 children aged 4-16 years (median 8.5 years) with epilepsy refractory to at least two antiepileptic drugs were treated with levetiracetam in addition to their present treatment regimen with a follow-up of 26 weeks. The starting dose of 10 mg/kg/day was increased with 2-week steps of 10 mg/kg/day, if necessary, up to a maximum dose of 60 mg/kg/day.


RESULTS
Retention rate was 69.7% after 26 weeks on a median levetiracetam dosage of 22 mg/kg/day. Four children dropped-out because levetiracetam was ineffective, four because seizure frequency increased and/or seizures became more severe, and two because they developed aggressive behaviour. Compared to their baseline seizure frequency, 13 children (39.4%) had a >50% seizure reduction 12 weeks after initiation of levetiracetam, and 17 children (51.5%) at 26 weeks. At 26 weeks, nine children (27.3%) had been seizure-free for at least the last 4 weeks, terminal remission ranged from 0 to 187 days (mean 46 days). Levetiracetam was effective in both partial and primary generalized seizures, but had most effect in partial seizures. Most reported side effects were hyperactivity (48.5%), somnolence (36.4%), irritability (33.3%) and aggressive behaviour (27.3%). Severity of most side effects was mild. Five children had a serious adverse event, which all concerned hospital admissions that were not related to levetiracetam use.


CONCLUSIONS
Levetiracetam proved to be an effective and well-tolerated add-on treatment in this group of children with refractory epilepsy.
Callenbach
Petra M C
PM
Department of Neurology, University Medical Centre Groningen, University of Groningen, P.O. Box 30 001, 9700 RB Groningen, The Netherlands. p.m.c.tijink@neuro.umcg.nl
Arts
Willem Frans M
WF
ten Houten
Robert
R
Augustijn
Paul
P
Gunning
W Boudewijn
WB
Peeters
Els A J
EA
Weber
Alma M
AM
Stroink
Hans
H
Geerts
Yvette
Y
Geerts
Ada T
AT
Brouwer
Oebele F
OF
D000293:Adolescent; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004351:Drug Resistance; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000523:psychology; D004829:Epilepsy, Generalized / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D012640:Seizures / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam