Biton 2011.
| Study characteristics | ||
| Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group multi‐centre study Number of control centres: 65 Country/Location: USA and Canada 2 treatment arms: 1 rufinamide, 1 placebo |
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| Participants | Participants: adolescents and adults (aged 12 to 80 years) with inadequately controlled focal‐onset seizures Gender: 46.9% male (rufinamide group 47.7%; placebo group 46.1%) Mean age (years): 37.3 (rufinamide group 36.4; placebo group 38.1) Mean weight (kg): 78.2 (rufinamide group 77.4; placebo group 79.0) Ethnic groups: black 9.3%; white 80.1%; Hispanic 7.6%; other 3.0% Median number of seizures: 13.3 (rufinamide group 13; placebo group 13.8) Duration of epilepsy: not reported Inclusion criteria: males or females, aged 12 to 80 years, with focal‐onset seizures with or without secondarily generalised seizures; person's seizures inadequately controlled on stable doses of up to 3 concomitantly administered AEDs, with no evidence of AED treatment non‐compliance Exclusion criteria: known generalised epilepsies or history of status epilepticus or seizure clusters in the past year, or requiring felbamate, vigabatrin, or rescue benzodiazepines; moreover, having clinically significant medical or psychiatric disease; clinically significant ECG abnormality; a diagnosis of congenital short QT syndrome; psychogenic seizures in the previous year; history of drug abuse and/or positive finding on urinary drug screening; or history of alcohol abuse in the past 2 years Diagnostic criteria: established by clinical history, electroencephalography, and CT/MRI of the brain performed within the last 10 years Comorbidities: none Comedications: ≤ 3 AEDs Total people randomised 357 (rufinamide group 176; placebo group 181). One participant was excluded from the analysis because required laboratory assessments were not obtained. 61 people withdrew from the study (rufinamide group 37; placebo group 24) |
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| Interventions | Intervention: rufinamide 3200 mg/d Control: placebo 2‐phase study: 56‐day baseline/screening phase; 96‐day treatment phase (12‐day titration period followed by 84‐day maintenance phase) |
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| Outcomes | Primary outcomes (as stated in publication)
Secondary outcomes (as stated in publication)
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| Notes | Stated aim of the study: "this randomized study was conducted to evaluate and confirm the efficacy and safety (seizure control and adverse effects) of rufinamide as adjunctive treatment for drug‐resistant focal‐onset seizures" Language of publication: English Commercial funding: yes Publication status (peer review journal): yes Publication status (journal supplement): no Publication status (abstract): no Funded by Eisai Medical Research No conflict of interest |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated schedule using blocks of 4 |
| Allocation concealment (selection bias) | Low risk | Participants allocated to each of the 2 treatment groups in a 1:1 ratio |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and clinical staff blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported. ITT efficacy analysis employed |
| Selective reporting (reporting bias) | Low risk | Protocol unavailable but appeared that all expected and pre‐specified outcomes were reported |
| Other bias | High risk | Sponsored by Eisai Inc., the manufacturer of rufinamide |