Conditions: Epilepsy Monotherapy
Keywords: Lacosamide Vimpat® Epilepsy Monotherapy Velocity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 888
Healthy volunteers: no

Brief summary:
Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Lacosamide intervention 2: Carbamazepine-Controlled Release
Intervention descriptions: intervention 1: Lacosamide:

* Strengths: 50 mg / 100 mg
* Form: tablets
* Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
* Duration: up to 118 weeks intervention 2: Carbamazepine-CR:

* Strengths: 200 mg
* Form: tablets
* Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
* Duration: up to 118 weeks

Protocol document: