Korean Topiramate Study Group 1999.

Methods	Randomised, double ‐blind, placebo ‐controlled study 2 treatment arms: 1 placebo, 1 topiramate Pre‐randomisation baseline period: 12 weeks Treatment period: 18 weeks
Participants	A multicentre study (Korea) 177 people were randomised (all with drug‐resistant focal epilepsy): 86 to placebo, 91 to topiramate Age range: 16 to 65 years Mean age: 29.8 years for placebo group, 29.6 years for topiramate group 54% males Other AEDs: 2 or fewer Median baseline monthly seizure frequency: 5.6 for placebo group, 5.6 for topiramate group
Interventions	600 mg topiramate per day or placebo
Outcomes	Median seizure frequency reduction rate Responder rate Seizure‐free rate Global evaluation by participant and physician Adverse effects
Notes	Trial sponsored by Janssen Korea Ltd
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: random number tables with permuted blocks of 4
Allocation concealment (selection bias)	Low risk	Comment: sealed, numbered packages allocated sequentially
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: 2 patients in the topiramate group and 1 in the placebo group were excluded from the analysis. It was determined that this did not represent a potentially clinically important impact Quote: "intention‐to‐treat analysis (ITTA) was performed for efficacy and safety measures"
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