Glauser 2008.
| Methods | Double‐blind, randomised, placebo‐controlled trial | |
| Participants | Total randomised: 138 Age range of patients = 4 to 30 The patients were all diagnosed with Lennox‐Gastaut syndrome. No specific mention of the level of intellectual disability was made. The patients had a minimum of 90 seizures in the month. They were on 1 to 3 fixed‐dose regimens of 1 to 3 concomitant AEDs. Baseline period = 28 days. Treatment period = 84 days (14 days titration + 17 days treatment) |
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| Interventions | Rufinamide versus placebo | |
| Outcomes | Primary = reduction in total seizure frequency, tonic‐atonic ("drop attack") seizure frequency and seizure severity rating Secondary = response to treatment (% of patient with at least 50% reduction in seizure frequency during the double‐blind phase); % change in seizure frequency per 28 days relative to baseline (for each seizure subtype other than tonic‐atonic); parental global evaluation (alertness, interaction with environment, daily activity performance, responsiveness to verbal request and seizure severity) |
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| Notes | Number used in data analysis 138 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information about how randomisation was achieved |
| Allocation concealment (selection bias) | Low risk | Numbers assigned to identical drugs |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and study personnel blinded by use of identical drugs |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comparable dropout rates across the groups. Intention‐to‐treat analysis carried out |
| Selective reporting (reporting bias) | Unclear risk | Protocol unavailable |
| Other bias | Unclear risk | No information about how trial was funded but no other evidence to suggest unclear risk of bias |