| Methods |
RCT, cross‐over |
| Participants |
Total randomised: 17
Age range of patients = 4.6 to 20.7 years, mean = 10.1 years (5/17 patients over 12 years)
All randomised patients had intellectual disability
All patients were taking 1 to 3 other AEDs
Baseline period = 8 weeks. Open phase = 2 to 12 months. Washout phase = 3 weeks. Each cross‐over leg = 12 weeks |
| Interventions |
Lamotrigine versus placebo |
| Outcomes |
Primary = % reduction in mean monthly seizure frequency
Secondary = severity of seizures, functional status of patient and frequency of adverse events |
| Notes |
Numbers used in data analysis = 15 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
LMG and placebo administered in random order ‐ does not say how random order was determined |
| Allocation concealment (selection bias) |
Low risk |
Randomisation carried out by pharmacological department |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Participants and study personnel blinded through use of identical placebo and LMG |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessors were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Reasons for dropouts unlikely to effect outcomes |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information |
| Other bias |
Unclear risk |
No information about how trial was funded and no other evidence to suggest other risk of bias |
