| Methods |
Randomised using 1:1 ratio, double‐blind, parallel design. This study was a second phase of a trial designed as 'responder‐enriched'. It followed an open‐label dose escalation trial. The LTG therapy was tapered over 2 weeks in the PCB group. The length of follow‐up for the randomised double‐blind study was 4 weeks. |
| Participants |
The individuals who became seizure free on LTG during a pre‐randomisation baseline randomised to continue LTG or to PCB. All participants who entered the preceding study were newly diagnosed children with typical AS. 29 participants were randomised, 15 into LTG group and 14 into PCB. 1 person in the LTG group withdrew consent. In the PCB group the age was 8.8+/‐3.1 years, 36% boys. In the LTG group the age was 6.9+/‐2.3 years, 36% were boys. |
| Interventions |
Monotherapy with LTG or PCB. |
| Outcomes |
Proportion of participants that remained seizure free, as measured by hyperventilation EEG. |
| Notes |
This study was sponsored by Glaxo Wellcome (now GlaxoSmithKline), makers of lamotrigine. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient information to permit judgement. |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Lamotrigine was and placebo were identically matched. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Lamotrigine was and placebo were identically matched. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Lamotrigine was and placebo were identically matched. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing outcome data. |
| Selective reporting (reporting bias) |
Low risk |
The study protocol is not available but it is clear that the published reports include all expected outcomes. |
