CBZ-CRCarbamazepine Controlled Release (medications)
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In a double-blind, active-controlled, non-inferiority study, 813 adults with newly or recently diagnosed epilepsy received either APTIOM (800, 1200 or 1600 mg, once-daily) or the active comparator carbamazepine controlled release (CBZ-CR; 200, 400 or 600 mg, twice-daily).
Bial, a Portugal-based pharmaceutical company, has revealed positive results for a pivotal phase three non-inferiority study comparing the efficacy and safety of eslicarbazepine acetate (ESL) to controlled release carbamazepine (CBZ-CR) as monotherapy in newly diagnosed adult patients with partial-onset seizures, it was reported yesterday.
The phase three study was a randomised, double-blind, parallel-group, active-controlled and non-inferiority study, investigating the efficacy and safety of once-daily ESL (800 to 1600 mg/daily) as monotherapy treatment for newly diagnosed adults with partial-onset seizures in comparison with twice-daily CBZ-CR (400 to 1200 mg/daily).