Rosenfeld 1996.
Methods | Double‐blind, placebo‐controlled, parallel‐group study 2 treatment arms: 1 placebo, 1 topiramate Prospective pre‐randomisation baseline period: 8 weeks Treatment period: 19 weeks | |
Participants | A multicentre study (USA)
209 people were randomised (all with drug‐resistant focal epilepsy): 42 to placebo, 167 to 1000 mg topiramate
Age range 18 to 65 years Mean age: Unknown 49% male Other AEDs: 1 Baseline seizure frequency (unknown). Patients had to have a minimum of 6 focal seizures during the 8‐week baseline phase |
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Interventions | 1000 mg topiramate per day or placebo | |
Outcomes | Proportion with a 50% reduction in seizure frequency | |
Notes | Limited information regarding trial. All information was provided by a single poster abstract. Trial sponsored by Johnson & Johnson |
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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 | Quote: "tablets were identical in appearance and packaging" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: only states "double‐blinded", and so blinding is likely though not confirmed |
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: appears all expected and prespecified outcomes are reported |
Other bias | Low risk | Comment: the study appears to be free of other sources of bias |