Add-on trials recruiting adults and children in which the number of children recruited could be determined
| Drug(s) | Number of children/number of participants | 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type | Design | Number of children experiencing ≥1 adverse event | Adverse event detection method* | Number of children withdrawn as a result of a suspected ADR | Outcome | Reference |
|---|---|---|---|---|---|---|---|---|---|---|
| Lamotrigine extended release vs placebo | 7/243 | ≥12 | 19 Weeks | Focal epilepsy | Double-blind | Not reported | Liverpool Adverse Event Profile | Not reported | Lamotrigine extended release more effective than placebo | Naritoku et al64 |
| Topiramate vs placebo | 21/80 | 3–59 | 20 Weeks | Primary generalised tonic-clonic seizures | Double-blind | Not reported | Not stated | Not reported | Topiramate more effective than placebo | Biton et al65 |
| Lamotrigine vs placebo | 45/121 (age 2–19 years) | ≥2 | 24 Weeks | Primary generalised tonic-clonic seizures | Double-blind | Not reported | Not stated | Lamotrigine 1/21; placebo 1/24 | Lamotrigine more effective than placebo | Biton et al,66 Trevathan et al67 |
| Levetiracetam vs placebo | 17/164 | 4–65 | 24 Weeks | Idiopathic generalised epilepsy | Double-blind | Not reported | Not stated | Not reported | Levetiracetam more effective than placebo | Berkovic et al68 |
↵* In addition to physical examination and laboratory parameters. ADR, adverse drug reaction.