Conditions: Partial Epilepsies
Keywords: Epilepsy Treatment Anti-epileptic drugs Seizures Vimpat
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 461
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Detailed description:
The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Arms:
arm 1: Lacosamide added to first adequate monotherapy (no history of Antiepileptic Drug \[AED\] polytherapy) and epilepsy diagnosis \< or = 24 months at Screening. arm 2: Lacosamide added to 1 to 3 Antiepileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis \> or = 5 years at Screening.

Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Oral Lacosamide:

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Protocol document: