Yamatogi 1997.
| Methods | RCT, parallel | |
| Participants | Total randomised: 80 Age range = 10 months to 17 years. Number of patients with intellectual disabilities = 61/66 Most patients were receiving 1 to 3 concomitant AEDs Baseline period = 4 weeks. Treatment period = 12 weeks | |
| Interventions | Clobazam versus clonazepam as comparator | |
| Outcomes | Primary efficacy = number of patients with a 50% or greater reduction in seizure frequency. Seizure frequency at the end of the treatment phase (12 weeks) was compared with the frequency at the end of the baseline period | |
| Notes | Numbers used in data analysis: 66 (CLB = 34, CZP = 32) used for efficacy data and 76 (CLB = 36, CZP = 40) used for safety data | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information about how randomisation achieved |
| Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Single‐blinded study |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 80 patients were randomised but only 66 and 76 were included in the analyses. Reasons for dropouts unavailable |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
| Other bias | Unclear risk | Insufficient information |
ABC: Aberrant Behaviour Checklist AED: antiepileptic drug CLB: clobazam CZP: clonazepam EEG: electroencephalography ELDQOL: Epilepsy and Learning Disabilities Quality of Life EOS: Epilepsy Outcome Scale FBM: felbamate LMG: lamotrigine RCT: randomised controlled trial VPA: valproic acid