Sachdeo 1999.

Methods	RCT, parallel
Participants	Total randomised: 98 Age range: topiramate group = 2 to 29 years (mean 11.2 years), placebo group = 2 to 42 years (mean 11.2 years). All patients had Lennox‐Gastaut syndrome, although the article does not make specific mention of the level of intellectual disability in this population All patients were receiving 1 to 3 concomitant AEDs Baseline period = 4 weeks. Followed by a 3‐week titration phase and an 8‐week maintenance phase
Interventions	Topiramate versus placebo
Outcomes	Primary efficacy determinants = (a) reduction in average monthly seizure rate for all seizure types combined; or (b) each component of a compound variable consisting of % reduction in drop attacks (tonic + atonic) and the parental global evaluation of seizure severity Secondary efficacy = (a) reduction in average monthly rate of major seizures (drop attacks + TC); (b) the % of patients considered to be treatment responders defined as those with a >= 50%, >= 75% or 100% reduction from baseline for drop attacks, major seizures and all seizures
Notes	Numbers used in data analysis = 98
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was computer‐generated
Allocation concealment (selection bias)	Low risk	Coded, opaque containers
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participants and study personnel "remained blinded to codes"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Participants and study personnel "remained blinded to codes"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unequal dropout rates across groups; reasons for dropouts not given
Selective reporting (reporting bias)	Low risk	All outcomes discussed were reported. There is no evidence to suggest outcomes were selectively reported
Other bias	Unclear risk	Funded by pharmaceutical company but no other evidence to suggest unclear risk of bias