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

Crawford 2001.

Methods Open‐label, parallel RCT
Participants Total randomised: 83
 All patients were 12 years and over. Age range = 15 to 59. All patients had intellectual disability
 All patients were taking 1 to 3 other AEDs
 Baseline period = 8 weeks. Titration period up to 14 weeks. Treatment period = minimum of 10 weeks
Interventions Gabapentin versus lamotrigine
Outcomes Primary efficacy = reduction in seizure frequency between baseline period and the last 8 weeks of the treatment period assessed using the R‐ratio=(T‐B)/(T+B) where T and B are the seizure frequencies per 28 days during treatment and baseline, respectively
Secondary = responders (seizure frequency reduced by 50% or more. Non‐responders = seizure frequency reduced by less than 50% and those withdrawing
Mood, behaviour and dependency were assessed
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Participants were sequentially randomised in blocks
Allocation concealment (selection bias) Unclear risk Insufficient information
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants were unblinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessment unblinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Although missing data and study attrition are unclear, an intention‐to‐treat analysis was carried out
Selective reporting (reporting bias) Low risk All outcomes discussed were reported. There is no evidence to suggest outcomes were selectively reported
Other bias Unclear risk Funded by a pharmaceutical company but no other evidence for other risk of bias