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

Author(s): Andrade R, Garcia-Espinosa A, Machado-Rojas A, Garcia-Gonzalez ME, Trapaga-Quincoses O, Morales-Chacon LM

Affiliation(s): Instituto Nacional Neurologia y Neurocirugia de Cuba, Ciudad de la Habana, Cuba. arletygarcia@infomed.sld.cu

Publication date & source: 2009-12-01, Rev Neurol., 49(11):581-6.

Publication type: English Abstract; Randomized Controlled Trial

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.

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