TOPIRAMATE MONOTHERAPY FOR PARTIAL ONSET SEIZURES

Purpose: Evaluation of topiramate (TPM) as monotherapy in patients wit h uncontrolled partial onset seizures. Methods: A total of 48 patients were evaluated in a double blind, parallel-group trial. During a 56-d ay baseline period, patients had at least eight partial onset seizures while being treated with one or two standard antiepileptic drugs (AED s). After 1-2 weeks of open-label treatment with TPM 100 mg/day, patie nts were randomly assigned, in equal proportions, to receive double-bl ind therapy with TPM 100 or 1,000 mg/day in a 5-week conversion and an 11-week monotherapy period. The study endpoint was completion of 112 study days (success) or fulfillment of one or more exit criteria: doub ling of average 28-day or highest 2-day baseline seizure rate, a gener alized tonic-clonic seizure (GTCS) if none had occurred at baseline, o r significant prolongation of generalized seizure duration. Results. T ime until exit was longer (p = 0.002) and success frequency was higher (p = 0.005) with TPM 1,000 as compared with 100 mg/day. Seizure-rate reductions of greater than or equal to 50, greater than or equal to 75 , or 100% were achieved by 46, 25, and 13% of the 1,000-mg/day group, respectively, as compared with 13, 8, and 0% of the 100-mg/day group, respectively. Most adverse events (AE) were mild or moderate in severi ty. Conclusions: Monotherapy with TPM 1,000 mg/day for partial onset s eizures with or without secondarily generalized seizures was effective , with a favorable safety profile.