| Methods |
RCT, cross‐over |
| Participants |
Total randomised: 26
Age range of patients = 11.7 to 18.3
Patients were divided into 2 groups according to seizure type and severity
Group I: 6 patients had secondary generalised epilepsy and 9 patients had partial epilepsy with or without secondary generalisation
Group II: 7 patients had secondary generalised epilepsy and 4 had partial epilepsy with or without secondary generalisation
3 patients had slight mental retardation, 7 had moderate mental retardation, 15 patients had serious mental retardation
Number of concomitant AEDs were not specified, however, patients were maintained on the drugs they were taking prior to the start of the study
Baseline period = 3 months, each cross‐over leg = 3 months, washout period = 3 months |
| Interventions |
Flunarizine versus placebo |
| Outcomes |
Primary efficacy variable not stated. Alterations in seizure frequency were recorded together with behavioural observations
In group I additional data were obtained, in patients with the ability to respond, on AEDs, EEG, attention test (Toulouse modified) |
| Notes |
Numbers used in data analysis = 26 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Does not say how patients were randomised |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Although it states that the trial was blinded, there is insufficient information regarding how blinding was achieved |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Although it states that the trial was blinded, there is insufficient information regarding how blinding was achieved |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No participants withdrew from the study |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information |
| Other bias |
Unclear risk |
Insufficient information |