Topiramate Monotherapy for Partial Onset Seizures

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Abstract
Summary: Purpose: Evaluation of topiramate (TPM) as monotherapy in patients with uncontrolled partial onset seizures. Methods: A total of 48 patients were evaluated in a doubleblind, parallel‐group trial. During a 56‐day baseline period, patients had at least eight partial onset seizures while being treated with one or two standard antiepileptic drugs (AEDs). After 1–2 weeks of open‐label treatment with TPM 100 mg/day, patients were randomly assigned, in equal proportions, to receive double‐blind 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: doubling of average 28‐ day or highest 2‐day baseline seizure rate, a generalized tonic‐clonic seizure (GTCS) if none had occurred at baseline, or significant prolongation of generalized seizure duration. Results: Time 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 50, 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 severity. Conclusions: Monotherapy with TPM 1,000 mg/day for partial onset seizures with or without secondarily generalized seizures was effective, with a favorable safety profile.

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