Project Description:
SP0993 is a Phase 3, multicenter, double-blind, double-dummy, randomized, positive-controlled study comparing the efficacy and safety of lacosamide (LCM) (target dose levels of 200, 400, or 600mg/day) to carbamazepine (controlled release) (CBZ-CR) (target dose levels of 400, 800, or 1200mg/day) used . . .
Key Inclusion and Exclusion Criteria:
Inclusion criteria Subjects must fulfill the following inclusion criteria to be eligible to participate in this study: 1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal repr . . .
Countries of Recruitment:
Australia, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied:
EPILEPSY AND EXPERIENCING PARTIAL-ONSET OR GENERALIZED TONIC-CLONIC SEIZURES