Evaluation of efficacy and safety of clobazam as an add-on drug in the treatment of generalized tonic-clonic seizure not controlled with valproic acid monotherapy.

Abstract

Epilepsy is one of the major neuron-damaging neurological disorders. Generalized tonic-clonic seizure (GTCS) is the commonest one. Refractory patterns cannot be controlled by simple monotherapy with antiepileptic drugs (AEDs). Valproic acid (VPA) is one of the widely prescribed AEDs but it may not control many cases up to its maximum tolerable doses. In this study, we have seen the safety and efficacy of clobazam to control seizure in the adult population as an add-on drug over valproate, in cases of valproate uncontrolled seizures. Patients on VPA monotherapy but not responding to it were recruited after applying inclusion and exclusion criteria and clobazam was added. There were two follow-ups at the interval of 6 months each. Seizure frequency and quality of life inventory in epilepsy-31 items (QOLIE-31) score were recorded to denote efficacy, and the occurrence of any adverse effect was also noted to elicit safety. Out of 101 patients, 78 were male and 23 were female. The most common age group was 18-30 y. Seizure frequency from 2.99 ± 0.95 decreased significantly on the third visit to 0.25 ± 0.43. QOLIE-31 scores of seizure worry, overall quality, emotional well-being, and cognition improved in the second follow-up. Fatigue, somnolence, and weight gain were the major side effects. Clobazam could be a good choice as an add-on in GTCS not controlled with VPA monotherapy. Clobazam definitely reduces seizure frequency and seizure worry and improves cognitive function and overall quality of life.