Glauser 2005

Methods	Randomised, double‐blind, placebo‐controlled, parallel‐group multi‐centre study. Number of control centres: not reported. Country/location: not reported. 2 treatment arms: 1 rufinamide, 1 placebo.
Participants	Participants: children aged 4‐16 years with refractory focal seizures. Gender: not reported. Mean age: not reported. Ethnic group: not reported. Median number of focal seizures: not reported. Duration of epilepsy: not reported. Inclusion criteria: children aged 4 to 16 years, with a diagnosis of uncontrolled focal seizures who were taking stable dosage of 1 or 2 concomitant AEDs. Exclusion criteria: not reported. Comorbidity: none. Comedication: ≤ 2 AEDs. Total people randomised 269. 1 participant excluded from analysis. 14 people withdrew from study: rufinamide group 10; placebo group 4.
Interventions	Intervention: rufinamide 45 mg/kg per day. Control: placebo. 2‐phase study: 56‐day baseline/screening phase, and 91‐day treatment phase (14‐day titration phase followed by 77‐day maintenance phase).
Outcomes	Primary outcomes (as stated in the publication): mean % reduction in total focal seizures frequency per 28 days during treatment phase relative to baseline. Secondary outcomes (as stated in the publication): total focal seizure frequency per 28 days; % responders (50%); adverse effects.
Notes	Stated aim of study: "This study aimed to assess the efficacy and safety (seizure control and adverse effects) of rufinamide as adjunctive therapy in paediatric patients with inadequately controlled primary focal seizures." Language of publication: English. Commercial funding: yes. Publication status (peer review journal): no. Publication status (journal supplement): no. Publication status (abstract): yes. Supported by Eisai Inc. No conflict of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details of randomisation provided.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information available to make judgement.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information available to make judgement.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No reasons reported for exclusion of 1 participant from analysis.
Selective reporting (reporting bias)	Low risk	Appeared all expected and prespecified outcomes were reported.
Other bias	High risk	Sponsored by Eisai Inc., the manufacturer of rufinamide.