Guberman 2002.

Methods	Randomised, double‐blind, placebo‐controlled study 3 treatment arms: 1 placebo, 2 topiramate Pre‐randomisation baseline period: 4 weeks Treatment period: 12 weeks
Participants	A multicentre study (Hungary, Poland, Israel, Canada, Russia, Czech Republic) 263 people were randomised (all with drug‐resistant focal epilepsy): 91 to placebo, 85 to topiramate escalated weekly by 25 mg/day to 200 mg/day, 83 to topiramate escalated weekly by 50 mg/day to 200 mg/day Age range: 18 to 67 years for placebo group, 18 to 64 years for topiramate groups Mean age: 36 years for placebo group, 37 years for topiramate groups 50% males for placebo group, 46% males for topiramate groups Other AEDs: 2 or fewer Median baseline monthly seizure frequency: 7 for placebo group, 7 for topiramate group
Interventions	200 mg topiramate per day escalated over 8 weeks by 25 mg/day increases weekly or 200 mg topiramate per day escalated over 4 weeks by 50 mg/day increases weekly or placebo
Outcomes	Primary outcome: medial % reduction from baseline in monthly focal‐onset seizure frequency for the combined topiramate groups versus placebo group Secondary outcomes: responder rate (50% reduction in seizure frequency) adverse effects other safety evaluation outcomes including clinical laboratory evaluations, neurology and physical examination, vital signs, and body weight measurements
Notes	Trial sponsored by Johnson & Johnson
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "randomized in equal proportions" Comment: insufficient information provided to determine judgement for sequence generation
Allocation concealment (selection bias)	Unclear risk	Comment: details regarding allocation concealment were not provided
Blinding (performance bias and detection bias) All outcomes	Low risk	Comment: identical tablets and packaging
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: it is likely that blinding was maintained
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: specific details of outcome assessment blinding not provided
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no concerns about missing data Quote: "intention‐to‐treat"
Selective reporting (reporting bias)	Low risk	Comment: protocol unavailable, but appears all expected and prespecified outcomes are reported
Other bias	Low risk	Comment: the study appears to be free of other sources of bias