Ng 2011.
| Methods | Double‐blind, placebo‐controlled RCT | |
| Participants | Total randomised: 238 patients with Lennox‐Gastaut syndrome; 177 participants completed the study Age range: 2 to 54 years; mean age: 12.4 years Approximately half of all participants were receiving concomitant valproic acid, valproate semisodium or valproate sodium | |
| Interventions | Placebo Low‐dose clobazam (0.25 mg/kg/day; maximum 10 mg/day) Medium‐dose clobazam (0.5 mg/kg/day; maximum 20 mg/day) High‐dose clobazam (1.0 mg/kg/day; maximum 40 mg/day) |
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| Outcomes | Baseline period: 4 weeks, treatment period 12 weeks. Outcomes assessed at week 4 and week 16 8‐item quality of life (QOL) questionnaire % decrease in weekly seizure frequency; overall seizure frequency Wechsler Adult Intelligence Scale (WAIS); Wechsler Intelligence Scale for Children (WISC) |
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| Notes | 217 participants were included in the analysis. Modified intention‐to‐treat analysis excluded 21 patients who did not have one or more daily seizures measurement in the 12‐week maintenance period | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central randomisation via interactive voice |
| Allocation concealment (selection bias) | Low risk | Central randomisation via interactive voice |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Although it states the trial was double‐blind there is insufficient information about how blinding was achieved |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Although it states the trial was double‐blind there is insufficient information about how blinding was achieved |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | High attrition rate. Modified intention‐to‐treat analysis carried out |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
| Other bias | High risk | Researchers were employed by pharmaceutical companies |