| Methods | Pilot, randomized controlled trial | |
| Participants | 28 participants with juvenile myoclonic epilepsy | |
| Interventions | Participants were assigned as 2:1 ratio to topiramate (19 participants) or valproate (9 participants) for 26 weeks. The topiramate target dosage was 3‐4 mg/kg/day (maximum 9 mg/kg/day) for participants aged 12‐16 years and 200 mg/day (maximum 600 mg/day) for participants aged > 16 years. Valproate target dosages were 10 mg/kg/day in participants aged 12‐16 years and 750 mg/day in participants aged >16 years (overall maximum 60 mg/kg/day). Medications were titrated at 1‐ to 2‐week intervals according to clinical response and were administered in divided doses | |
| Outcomes | Seizure reduction, evaluation of improvement, systemic toxicity and neurotoxicity scores, adverse events | |
| Notes | The baseline period was 3 months before study entry. A 14‐week titration phase was followed by a 12‐week maintenance phase | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Blinded randomization was achieved by providing study sites with individual envelopes containing medication assignments generated by computer |
| Allocation concealment (selection bias) | Low risk | Blinded randomization was achieved by providing study sites with individual envelopes containing medication assignments generated by computer |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participant, investigator and pharmacist remained blinded to medication assignment until screening was completed and the envelope was opened |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | The participant, investigator and pharmacist remained blinded to medication assignment until screening was completed and the envelope was opened |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 7 (37%) participants treated with topiramate and 2 (22%) participants treated with valproate discontinued before the endpoint |
| Selective reporting (reporting bias) | Unclear risk | No pre published protocol |
| Other bias | Low risk | No other bias was found |