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. 2019 Oct 23;2019(10):CD001417. doi: 10.1002/14651858.CD001417.pub4

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
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
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