To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy. Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks
Unnamed facility
Amiens, France
Unnamed facility
Aubenas, France
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study
Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Time frame: During the study ( up to 24 - 28 weeks)
Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study
Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Time frame: During the study (up to 24 - 28 weeks)
Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period
The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100. The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.
Time frame: End of Treatment Period (24-week)
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Unnamed facility
Auxerre, France
Unnamed facility
Bordeaux, France
Unnamed facility
Brest, France
Unnamed facility
Caen, France
Unnamed facility
Carpentras, France
Unnamed facility
Châteaubriand, France
Unnamed facility
Colmar, France
Unnamed facility
Créteil, France
...and 22 more locations