Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy; Partial Seizures
Intervention: Levetiracetam (Drug); Carbamazepine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: UCB Pharma SA Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of subjects remaining seizure free during the 6-months Evaluation Period
Secondary outcome: Proportion of subjects retained in the study for the duration of the period covering the Up Titration Period, Stabilization Period, and Evaluation PeriodTime to first seizure or discontinuation due to an Adverse Event (AE) / Lack of Efficacy (LOE) during the Evaluation Period Time to first seizure during the Evaluation Period Time to first seizure during the period covering the Up Titration Period, Stabilization Period, and Evaluation Period from the first dose of study drug
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
13, Beijing, China
16, Changchun City, China
10, Chengdu, China
5, Chengdu, China
4, Chongqing, China
26, Guangzhou City, China
1, Guangzhou, China
11, Guangzhou, China
20, Guangzhou, China
24, Hangzhou, China
22, Harbin, China
29, Kunming, China
23, Nanjing City, China
6, Nanjing City, China
8, Nanjing City, China
21, Nanjing, China
27, Qingdao, China
14, Shanghai, China
15, Shanghai, China
18, Shanghai, China
2, Shanghai, China
19, Shijiazhuang, China
3, Suzhou, China
9, Taiyuan, China
25, Tianjin, China
12, Wuhan, China
7, Xi'an, China
17, Xian, China
Additional Information
Starting date: September 2013
Last updated: August 12, 2015
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