DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF TOPIRAMATE (600 MG DAILY) FOR THE TREATMENT OF REFRACTORY PARTIAL EPILEPSY

Purpose: We wished to evaluate adjunctive therapy for partial-onset se izures with topiramate (TPM) for efficacy and safety in a double-blind , placebo-controlled, randomized, parallel-group study. Methods: Sixty outpatients with epilepsy (47 men and 13 women, mean age 32.9 years) were studied. All had a documented history of partial-onset seizures w ith or without secondarily generalized seizures. After an 8-week basel ine during which patients had at least one seizure per week, 30 patien ts each were randomized to TPM 300 mg twice daily (b.i.d.) or placebo for 12 weeks. Results: TPM was significantly superior to placebo, as i ndicated by all efficacy assessments: greater median percent reduction from baseline in the average monthly seizure rate (46 vs. - 12%, p = 0.004); greater number of treatment responders (patients with greater than or equal to 50% reduction in seizure rate) (47 vs. 10%, p = 0.001 ), and better investigator (p = 0.002) and patient (p = 0.010) global assessments of treatment. Among TPM-treated patients, the most commonl y reported adverse events (AE) were headache, somnolence, fatigue, diz ziness, and abnormal thinking, Most AE were mild or moderate in severi ty. Conclusions: The results of the present trial indicate that TPM 60 0 mg/day is effective in the treatment of refractory partial-onset sei zures with or without secondarily generalized seizures.