CLOBAZAM HAS EQUIVALENT EFFICACY TO CARBAMAZEPINE AND PHENYTOIN AS MONOTHERAPY FOR CHILDHOOD EPILEPSY

Purpose: To compare the effectiveness of monotherapy clobazam (CLB) to carbamazepine (CBZ) and phenytoin (PHT) in children with epilepsy. Me thods: Children aged 2-16 years with newly diagnosed epilepsy or previ ous failure of one drug (for poor efficacy or side effects) were assig ned to one of two study arms and then randomized-CLB versus CBZ or CLB versus PHT. Eligible children had partial epilepsies or only generali zed tonic-clonic seizures. After a drug initiation protocol, monothera py treatment mimicked the usual routines used by Canadian child neurol ogists. Blinding used a ''double dummy'' technique with blinded medica tion serum levels (6-point scale). Intention to treat analysis using s urvival curves assessed the primary end-point-length of retention on t he initial medication during the year after randomization. Results: Fi fteen centers entered 235 patients: 159 randomized to CLB versus CBZ a nd 76 to CLB versus PHT. Altogether, in all study arms, 119 received C LB, 78 CBZ, and 38 PHT. Overall, 56% continued to receive the original medication for 1 year with no difference between CLB and standard the rapy (CBZ and PI-IT). Seizure control was equivalent for all three med ications, as were side effects. PHT and CBZ induced more biologic side effects, such as rash, while CLB induced slightly more behavioral eff ects. Tolerance developed in 7.5% of patients receiving CLB, 4.2% with CBZ and 6.7% with PHT. Conclusions: CLB should be considered as ''fir st line'' monotherapy along with CBZ and Pi-IT for all partial and sel ected generalized childhood epilepsies.