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. 2015 Sep 3;2015(9):CD005399. doi: 10.1002/14651858.CD005399.pub3

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)
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)
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