Multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial of 692 patients aged 15 to 65 years (n=519 intent-to-treat TRILEPTAL patients)28-week, double-blind treatment phase. Median numbers of partial seizures per 28 days at baseline were: placebo (8.6); TRILEPTAL 600 mg (9.6); TRILEPTAL 1200 mg (9.8); TRILEPTAL 2400 mg (10.0). P values are for comparison with placebo.1,2
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Clear dose response across effective dosage range of 600 to 2400 mg/day1,2 |
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Prior to the addition of TRILEPTAL, patients were taking up to 3 AEDs, including1,2
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Carbamazepine (75%) |
Valproate (25%) |
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Phenytoin (21%) |
Lamotrigine (13%) |
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Study limitations
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36% of patients in the 1200-mg/day group and 67% in the 2400-mg/day group discontinued therapy due to adverse events (central nervous system [CNS]- and dose-related)2
No dosage adjustments were permitted for TRILEPTAL or the concomitant AEDs2
A rapid forced-titration schedule was required by the study protocol during the first 3 weeks of therapy2
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References:
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