Monotherapy trials involving children only
| Drug(s) | Number of children | Age range (years) | Duration | Epilepsy/seizure type | Design | Number of children experiencing ≥1 adverse event | Adverse event detection method* | Number of children withdrawn as a result of a suspected ADR | Outcome | Reference |
|---|---|---|---|---|---|---|---|---|---|---|
| Vigabatrin vs carbamazepine | 70 | 0.5–13.2 | 2 Years | Focal epilepsy | Open-label | Vigabatrin 16/38; carbamazepine 15/32 | Not stated | Vigabatrin 1/38; carbamazepine 6/32 | Similar efficacy | Zamponi et al12 |
| Vigabatrin vs carbamazepine | 26 | 5–17 | 24 Weeks | Focal epilepsy | Open-label | Not reported | Not stated | Vigabatrin 2/26; carbamazepine 0/38 | Similar efficacy | Sobaniec et al13 |
| Clobazam vs carbamazepine or phenytoin | 235 | 0.5–17 | 12 Months | Focal or primary generalised tonic-clonic | Double-blind | Not reported | Checklist of systemic and behavioural side effects | Clobazam 5/119; carbamazepine and phenytoin 17/116 | Clobazam as effective as carbamazepine or phenytoin | Canadian Study Group for Childhood Epilepsy14 |
| Conventional vs sustained release valproate | 48 | 5–14 | 16 Months | Newly diagnosed epilepsy | Open-label crossover | Conventional 17/48; sustained release 12–22/48 (dependent on dosing schedule) | Direct questioning | Conventional 0/48; sustained release 1/48 | Similar efficacy | Herranz et al15 |
| Lamotrigine vs placebo | 45 | 3–15 | 4 Weeks | Newly diagnosed absence seizures | Responder-enriched; double blind | Lamotrigine 44/45 | Not stated | Lamotrigine 0/45 | Lamotrigine more effective than placebo | Frank et al16 |
| Lamotrigine vs valproate | 38 | 3–13 | 12 Months | Newly diagnosed absence seizures | Open-label | Lamotrigine 6/19; valproate 2/19 | Diary | Lamotrigine 0/19; valproate 0/19 | Similar efficacy | Coppola et al17 |
| Sulthiamine vs placebo | 66 | 3–10 | 6 Months | Benign epilepsy with centrotemporal spikes | Double-blind | Not reported | Not stated | Sulthiamine 0/31 | Sulthiamine more effective than placebo | Rating et al18 |
| Levetiracetam vs oxcarbazepine | 39 | 3.3–14 | 18 Months | Benign epilepsy with centrotemporal spikes | Open-label | Levetiracetam 3/21; oxcarbazepine 2/18 | Not stated | Levetiracetam 1/21; oxcarbazepine 0/18 | Similar efficacy | Coppola et al19 |
| Vigabatrin vs placebo | 40 | 0.1–1.5 | 5 Days | Infantile spasms | Double-blind | Vigabatrin 12/20; placebo 6/20 | Not stated | Vigabatrin 0/20; placebo 0/20 | Vigabatrin more effective than placebo | Appleton et al20 |
| High dose vs low dose vigabatrin | 167 | 0–2 | 2 Weeks | Infantile spasms | Single-blind | Vigabatrin overall 150/167 (no. in each group not reported) | Not stated | Vigabatrin overall 9/167 (no. in each group not reported) | Vigabatrin more effective than placebo | Elterman et al21 |
| Hormone treatment vs vigabatrin | 107 | 0.1–1 | 14 Days | Infantile spasms | Open-label | Hormone treatment 30/55; vigabatrin 28/52 | Not stated | Hormone treatment 2/55; vigabatrin 0/52 | Hormone treatment more effective than vigabatrin | Lux et al22 |
↵* In addition to physical examination and laboratory parameters. ADR, adverse drug reaction.