Multicenter, randomized, double-blind, dose-controlled, monotherapy substitution trial in 87 patients ages 11 to 66 years (n=41 intent-to-treat [ITT] patients receiving 2400 mg/day of TRILEPTAL, n=46 ITT patients receiving 300 mg/day of TRILEPTAL)—126-day, double-blind phase. Median number of partial seizures per 28 days at baseline was 10.5 (range: 3 to 74) for the 2400 mg/day group and 6.5 (range: 2 to 49) for the control group.
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Prior to being converted to TRILEPTAL, patients were experiencing seizures even while taking clinically effective doses of at least one AED, including2
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— CBZ (54%) |
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— Phenytoin (20%) |
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— Other AEDs (such as valproate, lamotrigine, and gabapentin) |
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Effective seizure control in patients converted from CBZ
Reductions in Frequency of Partial Seizures Following Conversion From CBZ to TRILEPTAL Monotherapy2
Multicenter, open-label trial of 245 patients with partial seizures ages 12 to 81 years (n=109 ITT patients on CBZ monotherapy at study onset). In the 16-week treatment phase, patients were administered flexible doses of TRILEPTAL from 600 mg/day to 2400 mg/day. Median number of partial seizures per month prior to treatment with TRILEPTAL was 2.7.2
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Discontinuation rate due to adverse events was 11% for patients switched to TRILEPTAL from CBZ2 |
References:
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Adult Efficacy
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