Crumrine 1989.
| Methods | RCT, parallel | |
| Participants | Total randomised: 73 Age range of patients = 2 to 18 years. Mean age for cinromide group = 7.38 (± 3.65), mean age for placebo group = 7.93 (± 4.87). All patients had Lennox‐Gastaut syndrome, although level of intellectual disability was not stated Patients could be on no more than 3 other AEDs Baseline period = 6 weeks. Treatment period = 18 weeks | |
| Interventions | Cinromide versus placebo | |
| Outcomes | The primary statistical analysis of seizure frequency compared the changes from the baseline period (6 weeks) to the treatment period (12 weeks for most patients) in the cinromide and placebo groups Global evaluations at weeks 12, 18 and 24 were also compared |
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| Notes | Numbers used in data analysis = 56 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Although it states that participants were randomly assigned, information is not given about how randomisation was achieved |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Although it describes the trial as "double‐blind", there is insufficient information as to how blinding was achieved. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Although it describes the trial as "double‐blind", there is insufficient information as to how blinding was achieved. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Study attrition reported but reasons unclear |
| Selective reporting (reporting bias) | High risk | Very few P values reported |
| Other bias | High risk | Study was terminated early when it became clear to the funder that cinromide was not effective |