Table 2

Monotherapy trials recruiting adults and children in which the number of children recruited could be determined

Drug(s)Number of children/number of participantsAge range (years)DurationEpilepsy/seizure typeDesignNumber of children experiencing ≥1 adverse eventAdverse event detection method*Number of children withdrawn as a result of a suspected ADROutcomeReference
Lamotrigine vs carbamazepine233 (aged 2–12 years)/417≥224 WeeksFocal epilepsyOpen-labelLamotrigine 80/158; carbamazepine 47/75Not statedLamotrigine 8/158; carbamazepine 5/75Similar efficacyNieto-Barrera et al32
High dose vs low dose topiramate29/252≥3≥4 MonthsFocal epilepsyDouble-blind; conversion from another AEDNot reportedNot statedNot reportedHigh dose topiramate non-significantly more effective than low doseGilliam et al33
Carbamazepine vs gabapentin vs lamotrigine vs oxcarbazepine vs topiramate163/1721≥4At least 12 monthsFocal epilepsyOpen-labelNot reportedLiverpool Adverse Event ProfileNot reportedLamotrigine most effectiveMarson et al34
Topiramate vs carbamazepine or valproate119/613≥6≥6 MonthsNewly diagnosed epilepsyDouble-blindNot reportedNot statedTopiramate 200 7/39; topiramate 100 4/38; carbamazepine 1/23; valproate 6/19Topiramate as effective as carbamazepine or valproatePrivitera et al,35 Wheless et al38
High dose vs low dose topiramate151/470≥6≥6 MonthsNewly diagnosed epilepsyDouble-blindNot reportedNot statedHigh dose topiramate 11/77; low dose topiramate 3/74High dose topiramate more effective than low doseArroyo et al,36 Glauser et al39
Valproate vs lamotrigine vs topiramate191/716≥4At least 12 monthsGeneralised and unclassifiable epilepsyOpen-labelNot reportedLiverpool Adverse Event ProfileNot reportedValproate most effectiveMarson et al37
  • * In addition to physical examination and laboratory parameters. ADR, adverse drug reaction; AED, antiepileptic drugs.