[A prospective, open, controlled and randomised study of clobazam versus carbamazepine in patients with frequent episodes of Rolandic epilepsy]

Rev Neurol. 2009 Dec;49(11):581-6.
[Article in Spanish]


Introduction: To date no controlled, randomised studies with flexible dose regimens have been conducted in children with rolandic epilepsy, and therapy is therefore still empirical.

Aim: To evaluate the effectiveness and safety of clobazam (CLB) compared with that of carbamazepine (CBZ) in rolandic epilepsy.

Patients and methods: A prospective, open, controlled and randomised study was carried out to compare CBZ and CLB in children with rolandic epilepsy with a follow-up over a two-year period. A random sample of 45 patients was taken and 38 of them finished the study. A flexible dose regimen was indicated. Control of seizures, academic performance, behaviour, adherence to treatment, parents' degree of satisfaction and side effect profiles were all evaluated.

Results: Both drugs were equally effective at controlling seizures (94.1% of patients with CLB and 100% of those with CBZ were free of seizures on ending the study; p = 0.26). CLB controlled seizures earlier (33.3 +/- 45 days versus 48.2 +/- 72.3; p < 0.05) and had fewer side effects than CBZ (side effects appeared in three patients with CLB and in eight of those on CBZ; p = 0). In two of the patients taking CBZ, the seizures got worse and a series of cognitive-behavioural complications also appeared.

Conclusions: CBZ is an effective drug in rolandic epilepsy, but it may be associated with exacerbation of seizures as well as with cognitive-behavioural impairment. CLB in monotherapy seems to be an effective and better tolerated drug in this kind of epilepsy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Anticonvulsants / adverse effects
  • Anticonvulsants / therapeutic use*
  • Benzodiazepines / adverse effects
  • Benzodiazepines / therapeutic use*
  • Carbamazepine / adverse effects
  • Carbamazepine / therapeutic use*
  • Child
  • Child Behavior Disorders / chemically induced
  • Child, Preschool
  • Clobazam
  • Cognition Disorders / chemically induced
  • Epilepsy, Rolandic / drug therapy*
  • Epilepsy, Rolandic / physiopathology
  • Female
  • Humans
  • Male
  • Prospective Studies
  • Treatment Outcome


  • Anticonvulsants
  • Benzodiazepines
  • Clobazam
  • Carbamazepine