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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
436
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)
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)
13
Beijing, China
16
Changchun, China
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
Time frame: 6-months Evaluation Period (From Week 4 to Week 30)
Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
Time frame: From Week 1 to Week 30
Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Evaluation Period
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time frame: From Randomization (Week 1) up to Evaluation Visit (Week 30)
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10
Chengdu, China
5
Chengdu, China
4
Chongqing, China
11
Guangzhou, China
1
Guangzhou, China
20
Guangzhou, China
26
Guangzhou, China
24
Hangzhou, China
...and 18 more locations