Table 3

Add-on 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typeDesignNumber of children experiencing ≥1 adverse eventAdverse event detection method*Number of children withdrawn as a result of a suspected ADROutcomeReference
Gabapentin vs placebo247≤1212 WeeksFocal epilepsyDouble-blindNot reportedNot statedGabapentin 6/119; placebo 3/128Gabapentin more effective than placeboAppleton et al40
Topiramate vs placebo861–1616 WeeksFocal epilepsyDouble-blindNot reportedInterview in non-directed mannerTopiramate 0/41; placebo 1/45Topiramate more effective than placeboElterman et al41
Lamotrigine vs placebo2012–1618 WeeksFocal epilepsyDouble-blindLamotrigine 92/98; placebo 96/101Daily diary; verbal probeLamotrigine 5/98; placebo 6/101Lamotrigine more effective than placeboDuchowny et al42
Oxcarbazepine vs placebo2673–1716 WeeksFocal epilepsyDouble-blindOxcarbazepine 126/138; placebo 106/219Not statedOxcarbazepine 14/138; placebo 4/129Oxcarbazepine more effective than placeboGlauser et al43
High dose vs low dose oxcarbazepine1280.1–49 DaysFocal epilepsyRater-blindHigh dose 47/64; low dose 26/64Not statedHigh dose 3/64; low dose 2/64High dose oxcarbazepine more effective than low dosePiña-Garza et al44
Levetiracetam vs placebo1984–1614 WeeksFocal epilepsyDouble-blindLevetiracetam 89/101; placebo 89/97Spontaneous report; open-ended questionsLevetiracetam 5/101; placebo 9/97Levetiracetam more effective than placeboGlauser et al45
Stiripentol vs placebo32‘Child’2 MonthsFocal epilepsyDouble-blind; responder enriched; withdrawalStiripentol 12/17; placebo 4/15Not statedStiripentol 0/17; placebo 0/15Stiripentol more effective than placeboChiron et al46
Sulthiamine vs placebo370.3–1.259 DaysInfantile spasmsDouble-blindSulthiamine 9/20; placebo 9/17Not statedNot reportedSulthiamine more effective than placeboDebus et al47
Stiripentol vs placebo413–20.72 MonthsSevere myoclonic epilepsy of infancyDouble-blindStiripentol 21/21; placebo 5/21Not statedStiripentol 0/21; placebo 1/21Stiripentol more effective than placeboChiron et al48
Felbamate and valproate vs placebo and valproate134.2–15.714 WeeksLennox-GastautDouble-blind; crossoverNot reportedNot statedNot reportedFelbamate increases valproate levels leading to efficacySiegel et al49
Lamotrigine vs placebo302–22.524 WeeksRefractory generalised epilepsyDouble-blind; crossover; responder enrichedOverall 10/30InterviewOverall 0/30Lamotrigine more effective than placeboEriksson et al50
Antiepilepsirine vs placebo611–146.5 MonthsUndifferentiated epilepsyDouble-blind; crossoverAntiepilepsirine 1/34; placebo 0/34Psychological tests of behaviour and cognitive functionNot reportedAntiepilepsirine more effective than placeboWang et al51
Single dose IM clonazepam vs placebo101–1824 hUndifferentiated epilepsyDouble-blind; crossoverNot reportedNot statedNot reportedClonazepam more effective than placeboDahlin et al52
Black cumin seed extract vs placebo231–134 WeeksUndifferentiated epilepsyDouble-blind; crossoverOverall 3/23Not statedOverall 0/23Black cumin seed extract more effective than placeboAkhondian et al53
  • * In addition to physical examination and laboratory parameters.

  • ADR, adverse drug reaction; IM, intramuscular.