Skip to main content
. 2017 Jul 18;2017(7):CD008295. doi: 10.1002/14651858.CD008295.pub4
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
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:
  1. felbamate: 15.3 ± 22.1

  2. placebo: 12.3 ± 6.4


41 participants taking felbamate and 30 participants taking placebo completed the maintenance period.
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
Outcomes
  1. Reduction of seizure

  2. Greater than 50% reduction of seizure

  3. Treatment withdrawal

  4. Adverse effects

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