Clobazam monotherapy in drug naı̈ve adult patients with epilepsy

PURPOSE Evaluation of the efficacy and side effects profile of Clobazam in a 24-week open-labelled trial involving 26 cases of drug naïve adult patients with epilepsy. METHODS The study was an open labelled unicentre trial in which only drug naïve cases with epilepsy were included. A total of 26 cases were recruited. One case was dropped because he did not complete the desired follow up. Seizure type and frequency were recorded and follow up was done at 4, 8, 12, 18 and 24 weeks after initiation of therapy. The change in seizure severity, the dose of Clobazam required and development of side effects were recorded. RESULTS The seizure types included GTCS (n=16), complex partial seizures (n=4), focal motor seizures with secondary generalisation (n=3) and juvenile myoclonic epilepsy (n=2). Out of 25 patients, 16 (64%) became seizure free, while five (20%) had >50% reduction in their seizure frequency. Thus, these 21 patients (84%) were considered to be well controlled. The commonest side effect seen was sedation, which was noted in 4 of the 25 patients (16%). However, in none of these four patients sedation was significant enough to warrant stoppage of therapy. Weight gain, gait ataxia, loss of short-term memory and breakthrough seizures were noted in one patient each. CONCLUSIONS The efficacy of Clobazam coupled with the lack of significant side effects noted in our study makes it merit consideration as monotherapy in adult patients with epilepsy.