Multicenter, randomized, double-blind, dose-controlled, monotherapy substitution trial in 87 patients aged 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 as the control group) 126-day, double-blind treatment phase. Median numbers of partial seizures per 28 days at baseline were 10.5 for the 2400 mg/day group and 6.5 for the control group.1,2
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Prior to being converted to TRILEPTAL (2400 mg/day), patients were experiencing a median of 10.5 seizures per 28 days while taking therapeutic doses of up to 2 AEDs, including1
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Carbamazepine (54%) |
Phenytoin (20%) |
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Valproate (15%) |
Lamotrigine (12%) |
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Gabapentin (10%) |
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Long-term, open-label extension:
Data from 51% of patients who remained on TRILEPTAL monotherapy for up to 2 years3

Two-year, open-label extension phase of a multicenter, randomized, double-blind, dose-controlled, monotherapy substitution trial of 87 patients aged 11 to 66 years.3
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In an open-label extension phase of patients converted from up to 2 AEDs, all patients (N=76) either continued on TRILEPTAL monotherapy or received polytherapy as clinically needed3
51% of patients (n=39) remained on TRILEPTAL monotherapy
49% of patients (n=37) received polytherapy (not included in graph above)
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NEXT: See data on breakthrough partial seizures
References:
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