Conditions: Epilepsy Partial Seizures
Keywords: Levetiracetam Keppra Monotherapy China Epilepsy Partial-onset Seizures
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 436
Healthy volunteers: no

Brief summary:
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).

Detailed description:

Arms:
arm 1: Levetiracetam 1000 mg/day arm 2: Carbamazepine 400 mg/day

Interventions: intervention 1: Levetiracetam intervention 2: Carbamazepine
Intervention descriptions: intervention 1: Immediate release film-coated tablets at strengths of 250 mg and 500 mg.

* Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid)
* Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid
* Down-titration Period (Week 30 up to Week 33) intervention 2: Immediate release tablets at a strength of 200 mg.

* Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd)
* Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid
* Down-titration Period (Week 30 up to Week 33)

Protocol document: