Loiseau 1990.
| Methods | Randomised, double‐blind, cross‐over study. Two treatment arms: 1 placebo, 1 lamotrigine. Five phases: Pre‐randomisation baseline = 4 weeks. Treatment I = 8 weeks. Washout I = 4 weeks. Treatment II = 8 weeks. Washout II = 4 weeks. |
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| Participants |
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| Interventions | Add‐on lamotrigine or placebo. The median daily lamotrigine dose was 300 mg. Participants on valproate received lower doses. | |
| Outcomes | (1) 50% responder rates. (2) Withdrawal from study for any reason. (3) Adverse effects. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random permuted blocks. |
| Allocation concealment (selection bias) | Low risk | Participants were allocated by sequentially numbered, sealed packages containing either lamotrigine or placebo. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Neurologists, participants and parents were blinded. Investigators were blinded. All treatments (tablets) and packaging were identical. Pre‐packed coded medication dispensed by pharmacy. |
| Incomplete outcome data (attrition bias) | Low risk | No participants were excluded from analysis. 2 participants withdrew from the study; 1 receiving lamotrigine and 1 receiving placebo. The reasons for exclusion were reported. |
| Selective reporting (reporting bias) | Low risk | All outcomes stated in methods section of paper were reported in the results. There was no protocol available to check a priori outcomes. |
| Other bias | Unclear risk | This study was sponsored by GlaxoSmithKline, the manufactures of LTG. |