A prospective, open-label, randomized, multicenter study was conducted to evaluate the efficacy and safety of levetiracetam monotherapy in Japanese patients aged ≥16 years with newly or recently diagnosed epilepsy with partial-onset seizures. Of 71 patients randomized to 1 of 2 treatment groups: response-based titration (1,000 mg/day to 2,000 mg/day) or forced titration (3,000 mg/day) group, 70 (1,000 mg to 2,000 mg/day, n=61; 3,000 mg/day, n=9) were evaluable. The analysis of the primary efficacy variable, 6-month seizure freedom rate in the 1,000 mg/day to 2,000 mg/day group was 73.8% (45/61). In the 3,000 mg/day group, 2/9 (22.2%) patients achieved 6-month seizure freedom. Treatment-emergent adverse events (TEAEs) were reported by 63/71 (88.7%) patients, which consisted of 54/61 (88.5%) in the 1,000 mg/day to 2,000 mg/day group and 9/10 (90.0%) in the 3,000 mg/day group. The most frequently reported TEAEs were nasopharyngitis in 33 patients (46.5%) followed by somnolence in 25 (35.2%), malaise in 8 (11.3%), and dizziness in 7 (9.9%). The safety profile of levetiracetam in monotherapy was similar to that of use in add-on therapy. These data suggest that levetiracetam monotherapy is efficacious and safe in Japanese patients aged #8805;16 years with newly or recently diagnosed partial-onset epilepsy.
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