Clinical trial NCT01954121: Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Partial Seizures
Keywords: Levetiracetam
Keppra
Monotherapy
China
Epilepsy
Partial-onset Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 436
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
timeFrame: 6-months Evaluation Period (From Week 4 to Week 30)
Secondary outcomes:
measure: Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
timeFrame: From Week 1 to Week 30
measure: Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period
timeFrame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
measure: Time to First Seizure During the Evaluation Period
timeFrame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
measure: Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug
timeFrame: From Randomization (Week 1) up to Evaluation Visit (Week 30)
Other outcomes:
Locations:
city: Beijing
country: China
facility: 13
city: Changchun City
country: China
facility: 16
city: Chengdu
country: China
facility: 10
city: Chengdu
country: China
facility: 5
city: Chongqing
country: China
facility: 4
city: Guangzhou City
country: China
facility: 26
city: Guangzhou
country: China
facility: 11
city: Guangzhou
country: China
facility: 1
city: Guangzhou
country: China
facility: 20
city: Hangzhou
country: China
facility: 24
city: Harbin
country: China
facility: 22
city: Kunming
country: China
facility: 29
city: Nanjing City
country: China
facility: 23
city: Nanjing City
country: China
facility: 6
city: Nanjing City
country: China
facility: 8
city: Nanjing
country: China
facility: 21
city: Qingdao
country: China
facility: 27
city: Shanghai
country: China
facility: 14
city: Shanghai
country: China
facility: 15
city: Shanghai
country: China
facility: 18
city: Shanghai
country: China
facility: 2
city: Shijiazhuang
country: China
facility: 19
city: Suzhou
country: China
facility: 3
city: Taiyuan
country: China
facility: 9
city: Tianjin
country: China
facility: 25
city: Wuhan
country: China
facility: 12
city: Xi'an
country: China
facility: 7
city: Xian
country: China
facility: 17
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: