Methods | Randomised, double‐blind, placebo‐controlled trial 8‐week baseline period, a period of gradual increase of the drug to the maximum tolerated dose, and 8‐week maintenance phase |
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Participants | Multicenter study 83 participants (mean age 33.5 years) were enrolled and randomised, 45 to felbamate and 38 to placebo The average monthly seizure frequency in baseline period:
41 participants taking felbamate and 30 participants taking placebo completed the maintenance period. |
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Interventions | Add‐on felbamate or placebo A period of gradual increase of the drug to the maximum tolerated dose, but not higher than 3600 mg/d, and then an 8‐week maintenance phase |
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Outcomes |
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Notes | 4 participants receiving felbamate withdrew from the study. In two cases treatment discontinuation was caused by adverse events (diplopia in one case, asthenia and collapse in the other). 1 participant died from the consequences of a seizure, the fourth withdrew consent to continue the trial. 8 participants treated with placebo did not complete the study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Selective reporting (reporting bias) | Unclear risk | There was no description |
Random sequence generation (selection bias) | Unclear risk | There was no description |
Allocation concealment (selection bias) | Unclear risk | There was no description |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | There was no description |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There was no description |
Incomplete outcome data (attrition bias) All outcomes | High risk | 71/83 completed the maintenance period |