Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Japan Co. Ltd.
With
Parexel
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is Japanese and enrolled in EP0009 (NCT01832038) receiving oral Lacosamide (LCM) for the treatment of partial-onset seizures and has been enrolled for at least 8 weeks
Subject has been on a stable twice daily (bid) dosage regimen of LCM 200 mg/ day to 400 mg/ day, for the 2 weeks prior to entry into EP0024
Subject has been receiving no more than 3 concomitant Antiepileptic Drugs (AEDs) at doses that have remained stable for the 2 weeks prior to entry into EP0024
You may not be if
Subject has a history of any kind of status epilepticus within 12-month period prior to study entry
Subject has actual suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
