| Methods |
RCT, cross‐over |
| Participants |
Total randomised: 20
Number of patients over the age of 12 = 11/13. Age range 6 to 18 years (mean age 12 years 7 months). Number of patients with intellectual disability = 12/13
Most patients on 2 to 3 other AEDs
Baseline = 16 weeks
No titration period
Treatment phase 1 and 2 = 16 weeks each |
| Interventions |
Flunarizine versus placebo |
| Outcomes |
Primary efficacy = total number of seizures |
| Notes |
Numbers used in data analysis = 13/20 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States "randomised sequence" but does not say how this was achieved |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Although the trial is described as "double blind", no information is given to describe how blinding was achieved |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Although the trial is described as "double blind", no information is given to describe how blinding was achieved |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Attrition may be due to adverse effects and no intention‐to treat‐analysis appears to have been carried out |
| Selective reporting (reporting bias) |
Low risk |
All outcomes discussed in the methods section were reported in the results and all P values were reported |
| Other bias |
High risk |
Lack of protocol and insufficient information regarding the methodology. Funded by a pharmaceutical company |
