Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

Study Overview
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Brief Summary
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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).

Official Title
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An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures

Conditions
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Epilepsy, Partial Seizures

Intervention / Treatment
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* Drug: Levetiracetam
* Drug: Carbamazepine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is of Chinese origin and ≥ 16 years of age Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS) Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS Exclusion Criteria: Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS) Subject has only experienced type IA nonmotor seizures Subject has a history or presence of seizures occurring only in clustered patterns Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures Subject has a history of Status Epilepticus

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam<br>Levetiracetam 1000 mg/day | Drug: Levetiracetam<br>* 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)<br>* Other names: Keppra;|
| Active Comparator: Carbamazepine<br>Carbamazepine 400 mg/day | Drug: Carbamazepine<br>* 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)<br>* Other names: Tegretol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period |  | 6-months Evaluation Period (From Week 4 to Week 30) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period |  | 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. | 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. | 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. | From Randomization (Week 1) up to Evaluation Visit (Week 30) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levetiracetam, Keppra, Monotherapy, China, Epilepsy, Partial-onset Seizures