Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
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
1 other identifier
interventional
436
1 country
28
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2013
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
August 11, 2016
CompletedAugust 15, 2017
July 1, 2017
2 years
September 26, 2013
March 18, 2016
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
6-months Evaluation Period (From Week 4 to Week 30)
Secondary Outcomes (4)
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)
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)
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)
Study Arms (2)
Levetiracetam
EXPERIMENTALLevetiracetam 1000 mg/day
Carbamazepine
ACTIVE COMPARATORCarbamazepine 400 mg/day
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma SAlead
Study Sites (28)
13
Beijing, China
16
Changchun, China
10
Chengdu, China
5
Chengdu, China
4
Chongqing, China
11
Guangzhou, China
1
Guangzhou, China
20
Guangzhou, China
26
Guangzhou, China
24
Hangzhou, China
22
Harbin, China
29
Kunming, China
21
Nanjing, China
23
Nanjing, China
6
Nanjing, China
8
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
17
Xi'an, China
7
Xi'an, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Cares
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2013
First Posted
October 1, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
August 15, 2017
Results First Posted
August 11, 2016
Record last verified: 2017-07