Table 1

Monotherapy trials involving children only

Drug(s)Number of childrenAge 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typeDesignNumber of children experiencing ≥1 adverse eventAdverse event detection method*Number of children withdrawn as a result of a suspected ADROutcomeReference
Vigabatrin vs carbamazepine700.5–13.22 YearsFocal epilepsyOpen-labelVigabatrin 16/38; carbamazepine 15/32Not statedVigabatrin 1/38; carbamazepine 6/32Similar efficacyZamponi et al12
Vigabatrin vs carbamazepine265–1724 WeeksFocal epilepsyOpen-labelNot reportedNot statedVigabatrin 2/26; carbamazepine 0/38Similar efficacySobaniec et al13
Clobazam vs carbamazepine or phenytoin2350.5–1712 MonthsFocal or primary generalised tonic-clonicDouble-blindNot reportedChecklist of systemic and behavioural side effectsClobazam 5/119; carbamazepine and phenytoin 17/116Clobazam as effective as carbamazepine or phenytoinCanadian Study Group for Childhood Epilepsy14
Conventional vs sustained release valproate485–1416 MonthsNewly diagnosed epilepsyOpen-label crossoverConventional 17/48; sustained release 12–22/48 (dependent on dosing schedule)Direct questioningConventional 0/48; sustained release 1/48Similar efficacyHerranz et al15
Lamotrigine vs placebo453–154 WeeksNewly diagnosed absence seizuresResponder-enriched; double blindLamotrigine 44/45Not statedLamotrigine 0/45Lamotrigine more effective than placeboFrank et al16
Lamotrigine vs valproate383–1312 MonthsNewly diagnosed absence seizuresOpen-labelLamotrigine 6/19; valproate 2/19DiaryLamotrigine 0/19; valproate 0/19Similar efficacyCoppola et al17
Sulthiamine vs placebo663–106 MonthsBenign epilepsy with centrotemporal spikesDouble-blindNot reportedNot statedSulthiamine 0/31Sulthiamine more effective than placeboRating et al18
Levetiracetam vs oxcarbazepine393.3–1418 MonthsBenign epilepsy with centrotemporal spikesOpen-labelLevetiracetam 3/21; oxcarbazepine 2/18Not statedLevetiracetam 1/21; oxcarbazepine 0/18Similar efficacyCoppola et al19
Vigabatrin vs placebo400.1–1.55 DaysInfantile spasmsDouble-blindVigabatrin 12/20; placebo 6/20Not statedVigabatrin 0/20; placebo 0/20Vigabatrin more effective than placeboAppleton et al20
High dose vs low dose vigabatrin1670–22 WeeksInfantile spasmsSingle-blindVigabatrin overall 150/167 (no. in each group not reported)Not statedVigabatrin overall 9/167 (no. in each group not reported)Vigabatrin more effective than placeboElterman et al21
Hormone treatment vs vigabatrin1070.1–114 DaysInfantile spasmsOpen-labelHormone treatment 30/55; vigabatrin 28/52Not statedHormone treatment 2/55; vigabatrin 0/52Hormone treatment more effective than vigabatrinLux et al22
  • * In addition to physical examination and laboratory parameters. ADR, adverse drug reaction.