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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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.
Authors: Mark A Kramer; Lauren M Ostrowski; Daniel Y Song; Emily L Thorn; Sally M Stoyell; McKenna Parnes; Dhinakaran Chinappen; Grace Xiao; Uri T Eden; Kevin J Staley; Steven M Stufflebeam; Catherine J Chu Journal: Brain Date: 2019-05-01 Impact factor: 13.501