A Multicenter, Double Blind, Double Dummy, Randomized, Positive Controlled Study Comparing The Efficacy And Safety Of Lacosamide (200 To 600mg/Day) To Controlled Release Carbamazepine (400 To 1200mg/Day), Used As Monotherapy In Subjects (?16 Years) Newly
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Last updated:6th Sep 2010
The objective of this study is to compare the efficacy and safety of Lacosamide (LCM) (200 to 600mg/day) to Carbamazepine Controlled release CBZ CR (400 to 1200mg/day) used as monotherapy for at least 1 year, efficacy being measured as a primary endpoint by 6 month seizure freedom, in newly or recently diagnosed epilepsy subjects. The study will employ a noninferiority design to show at least a similar benefit risk balance for LCM compared with CBZ CR, using 6-month seizure freedom as primary endpoint.
|Study start date||2010-09-06|