Double-blind randomized trial comparing efficacy, safety and tolerance between Levetiracetam monotherapy and Valproic acid monotherapy in children with newly diagnosed epilepsy
Projectomschrijving
De onderzoekers wilden bekijken of bij kinderen met epilepsie het nieuwe medicijn levetiracetam even effectief is als het meest gebruikte valproïnezuur, maar beter wordt verdragen. Ook keken ze naar de invloed van de medicatie op het algeheel functioneren. Helaas zijn slechts 15 patiënten geïncludeerd. De consequentie hiervan is dat er geen evaluatie van de resultaten over effectiviteit en veiligheid van levetiracetam en valproïnezuur plaats kan vinden.
Wel proberen de onderzoekers antwoord te geven op de vraag of de behandeling met levetiracetam of valproïnezuur in de kleine groep geïncludeerde kinderen heeft geleid tot veranderingen in het algeheel functioneren. Aangezien de patiënten net gestopt zijn met de studie zijn deze resultaten nog niet bekend. De onderzochte groep is erg klein en het is onbekend of de onderzoekers daadwerkelijk tot een zinvolle interpretatie kunnen komen. Verder onderzoeken ze de redenen van de tegenvallende inclusie.
Producten
Auteur: Weijenberg, Amerins, Callenbach, Petra M. C., Brouwer, Oebele F.
Magazine: Epilepsia Open
Verslagen
Eindverslag
Samenvatting van de aanvraag
Very few antiepileptic drugs (AEDs) are licensed for initial use as monotherapy in children with newly diagnosed epilepsy. Valproic acid (VPA) is the most frequently prescribed AED in children with epilepsy in the Netherlands [1,2] due to its effectiveness in a broad spectrum of different seizure types [3,4]. It is however related to a number of side effects, some of which may be very serious [3-5]. An efficacious and broad spectrum AED with a better safety profile that can be used as monotherapy in children is therefore needed. This double-blind, multi-centre study investigates the efficacy, safety and tolerability of levetiracetam (LEV) monotherapy 15-60mg/kg/day versus VPA monotherapy 10-40mg/kg/day as a first-line treatment in children aged 4 to 16 years with newly diagnosed epilepsy in the Netherlands. At least three large academic centres (Groningen, Utrecht, Maastricht) with paediatric neurology departments and close cooperation with 5-10 paediatric centres per academic centre, and five paediatric neurologists from general hospitals will participate. 200 Children with at least 2 seizures in the last 4 weeks before enrolment and no previous treatment for their seizures will be randomized double-blindly to be treated with levetiracetam or valproic acid if initiation of AEDs is indicated. The trial will last up to 52 weeks for each child with regular visits. The primary efficacy variable is retention rate after 52 weeks of treatment comparing LEV versus VPA. Secondary outcomes are influence of treatment on cognitive development and quality of life, terminal remission, time to withdrawal from study treatment, percentage of patients being seizure-free on AED treatment after 26 weeks and 52 weeks, percentage of patients with seizure reduction of more than 50% after 52 weeks, and incidence of side-effects. The outcomes will be determined for the group as a whole and for the epilepsy syndromes that occur most frequently in our cohort.