Faught 1996.
| Methods | Double‐blind, placebo‐controlled, parallel‐group study 4 treatment arms: 1 placebo, 3 topiramate Pre‐randomisation baseline period: 12 weeks Treatment period: 16 weeks | |
| Participants | A multicentre study (USA)
181 people were randomised (all with drug‐resistant focal epilepsy): 45 to placebo, 45 mg to 200 mg per day topiramate, 45 mg to 400 mg per day topiramate, 46 mg to 600 mg per day topiramate
Age range: 19 to 68 years Mean age: 36.9 years Other AEDs: 2 or fewer 70% males Median baseline monthly seizure frequency: 10.8 (10.0 for placebo group, 11.5 for 200 mg/d topiramate group, 11.0 for 400 mg/d topiramate group, 11.2 for 600 mg/d topiramate group) |
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| Interventions | 200 mg topiramate per day or 400 mg topiramate per day or 600 mg topiramate per day or placebo | |
| Outcomes |
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| Notes | Trial sponsored by Johnson & Johnson | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random permuted blocks |
| 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: no concerns about missing data Quote: "intention‐to‐treat efficacy analysis" |
| 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 |