GABAPENTIN MONOTHERAPY .2. A 26-WEEK, DOUBLE-BLIND, DOSE-CONTROLLED, MULTICENTER STUDY OF CONVERSION FROM POLYTHERAPY IN OUTPATIENTS WITH REFRACTORY COMPLEX PARTIAL OR SECONDARILY GENERALIZED SEIZURES

This study evaluated gabapentin monotherapy in 275 patients with medic ally refractory complex partial or secondarily generalized seizures wh o were taking one or two antiepileptic drugs (AEDs). Following an 8-we ek baseline, patients received randomized dosages of gabapentin (600, 1,200, or 2,400 mg/d) during a 26-week double-blind phase comprising 2 weeks gabapentin add-on therapy, an 8-week AED taper, and a 16-week g abapentin monotherapy period. Patients exited the study if they experi enced a protocol-defined exit event. Results of outcome measures, incl uding time to exit, completion rate, and mean time on monotherapy, sho wed no significant differences among dosage groups, Possible reasons f or this lack of a dose-response relationship include withdrawal seizur es and the limited range of gabapentin dosages studied. Overall, 20% o f patients completed the study. Completion rates were higher among pat ients who had discontinued one AED (23%) than two AEDs (14%), and high er among patients who were not withdrawn from carbamazepine (27%) than among those who were (16%).