Baulac 2010.

Methods	Double‐blind, placebo‐controlled, randomised, parallel‐group study. Three arms: 1 placebo, 1 lamotrigine, and 1 pregabalin. Baseline period = 6 weeks; double‐blind treatment period = 17 weeks, which included initial 5 weeks dosage titration for lamotrigine and 6 weeks maintenance at 300 mg/day and additional treatment period of 6 weeks with dose escalation to 400 mg/day for those with continuing seizures. Double‐blind treatment period was followed by an open‐label study or a 2‐week taper phase.
Participants	97 centres in Europe, Canada, and Australia. Adults over the age of 18 years and body weight ≥40 kg, with a diagnosis of partial seizures (as defined by the International League Against Epilepsy Classification of Seizures). 546 persons screened, 434 randomised. M:F ratio 39.3:60.7 for placebo and 54.6:45.4 for lamotrigine. Mean age 39.1 in placebo group and 39.4 in Lamotrigine group. Minimum seizure frequency of 4 partial seizures during the 6‐week baseline period and no 28‐day period free of partial seizure, despite treatment with at least three AEDs from at least two different AED classes, each at or above the lowest recommended dose or the lowest adequate plasma concentration given for a minimum of 3 months; were allowed to take one to three AEDs concurrently, one of which had to be an enzyme inducer. Exclusion Criteria: previous treatment with pregabalin; previous treatment with lamotrigine within 6 months before entering baseline; history of rash with lamotrigine; previous treatment with valproic acid products within 2 months of baseline; and previous treatment with gabapentin, felbamate, or vigabatrin < 6 weeks prior to screening. history of status epilepticus in the last 1 year, significant psychiatric disorder, or use of concomitant medication that could interfere with response to study medications or affect seizure frequency. pregnant or planning to conceive, lactation.
Interventions	Group I (n = 141): received placebo. Group II (n = 141): received lamotrigine 300 mg/day after dose titration over 5 weeks, and if seizures occurred during 6‐week maintenance, further dose escalation to 400 mg/day from week 12 to 17. Group III (n = 152): received pregabalin.
Outcomes	(1) Seizure frequency. (2) Adverse events, including changes in physical and neurologic examinations, 12‐lead electrocardiograms (ECGs), and clinical laboratory tests (hematology, blood chemistry, pregnancy, and urinalysis).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not specified.
Allocation concealment (selection bias)	Unclear risk	The details were not mentioned in the publication.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	No details provided regarding blinding of participants, study personnel, and outcome assessors. Regarding the medications, blinding was maintained by administering the same numbers of capsules per day per group.
Incomplete outcome data (attrition bias)	Low risk	35 withdrew from placebo group and 40 from lamotrigine group. The reasons for exclusion were reported.
Selective reporting (reporting bias)	Low risk	Protocol unavailable to check a priori outcomes, but appears all expected and pre‐specified outcomes are reported.
Other bias	Unclear risk	Responder rates were mentioned as percentages and actual numbers were not given. Author has been contacted regarding actual number of responders in each group. This study was sponsored by Pfizer Inc.