| Methods |
RCT, parallel |
| Participants |
Total randomised: 73
Age range = 4 to 36 years. All patients had Lennox‐Gastaut syndrome, although the article does not make specific mention of the level of intellectual disability in this population
Patients could not be on more than 2 AEDs before study initiation
Baseline period = 28 days. Felbamate or placebo was administered for 70 days. Felbamate was titrated during the 1st 14 days of the treatment phase to a maximum of 45 mg/kg/day or 3600 mg/day, whichever was less. Followed by a 56‐day maintenance period |
| Interventions |
Felbamate versus placebo |
| Outcomes |
Primary efficacy = (a) frequency of seizures during a 4‐hour period of video recording performed at same time of day; (b) a compound variable consisting of parents' or guardians' global evaluations and their counts of atonic seizures
Secondary efficacy = (a) parental counts of total seizures; (b) parental counts of generalised tonic‐clonic seizures
Evaluation of safety = monitoring adverse events, vital signs and body weight
General physical and neurologic examinations, measurements of plasma concentrations of felbamate and standard antiepileptic drugs and clinical laboratory evaluations |
| Notes |
Numbers used in data analysis = 71 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was computer‐generated |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Although it states that participants and study personnel were blinded, there is no information about how this blinding was achieved |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Study personnel blinded. Independent team completed data analysis |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1 dropout in each group; all participants included in the analysis |
| 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 |
Information on funding unavailable and no other evidence to suggest unclear risk of bias |
