Conditions: Epilepsy, Partial
Keywords: Vimpat Partial seizures Carbamazepine Hormone levels Lipid levels Lacosamide
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
The purpose of the trial is to investigate whether changes in lipids and hormonal parameters can be observed in blood when Carbamazepine treatment is replaced with Lacosamide treatment, while Levetiracetam treatment remains unchanged.

Detailed description:

Arms:
arm 1: commercial 50 mg (pinkish) and 100 mg (yellow) tablets

Interventions: intervention 1: Lacosamide intervention 2: Levetiracetam
Intervention descriptions: intervention 1: 4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks. intervention 2: Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time.

Protocol document: