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

Phase 3

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Levetiracetam	Levetiracetam	Levetiracetam 1000 mg/day
Carbamazepine	Carbamazepine	Carbamazepine 400 mg/day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)	Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time to First Seizure During the Evaluation Period	From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)	Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug	From Randomization (Week 1) up to Evaluation Visit (Week 30)	Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.

Locations (28): 16
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Changchun City, China
1
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Guangzhou, China
20
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Guangzhou, China
4
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Chongqing, China
26
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Guangzhou City, China
13
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Beijing, China
10
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Chengdu, China
27
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Qingdao, China
5
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Chengdu, China
22
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Harbin, China
11
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Guangzhou, China
24
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Hangzhou, China
29
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Kunming, China
8
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Nanjing City, China
23
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Nanjing City, China
6
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Nanjing City, China
15
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Shanghai, China
14
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Shanghai, China
18
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Shanghai, China
2
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Shanghai, China
19
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Shijiazhuang, China
12
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Wuhan, China
9
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Taiyuan, China
3
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Suzhou, China
25
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Tianjin, China
7
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Xi'an, China
17
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Xian, China
21
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Nanjing, China