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. 2015 Sep 3;2015(9):CD005399. doi: 10.1002/14651858.CD005399.pub3

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)
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)
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