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

Primary Purpose

Epilepsy, Partial Seizures

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Levetiracetam
Carbamazepine
Sponsored by
UCB Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Keppra, Monotherapy, China, Epilepsy, Partial-onset Seizures

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 13
  • 16
  • 10
  • 5
  • 4
  • 26
  • 11
  • 1
  • 20
  • 24
  • 22
  • 29
  • 23
  • 6
  • 8
  • 21
  • 27
  • 14
  • 15
  • 18
  • 2
  • 19
  • 3
  • 9
  • 25
  • 12
  • 7
  • 17

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levetiracetam

Carbamazepine

Arm Description

Levetiracetam 1000 mg/day

Carbamazepine 400 mg/day

Outcomes

Primary Outcome Measures

Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period

Secondary Outcome Measures

Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
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.
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.
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.

Full Information

First Posted
September 26, 2013
Last Updated
July 6, 2017
Sponsor
UCB Pharma SA
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1. Study Identification

Unique Protocol Identification Number
NCT01954121
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial Seizures
Keywords
Levetiracetam, Keppra, Monotherapy, China, Epilepsy, Partial-onset Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Levetiracetam 1000 mg/day
Arm Title
Carbamazepine
Arm Type
Active Comparator
Arm Description
Carbamazepine 400 mg/day
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Carbamazepine
Other Intervention Name(s)
Tegretol
Intervention Description
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)
Primary Outcome Measure Information:
Title
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
Time Frame
6-months Evaluation Period (From Week 4 to Week 30)
Secondary Outcome Measure Information:
Title
Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period
Time Frame
From Week 1 to Week 30
Title
Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period
Description
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time Frame
From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Title
Time to First Seizure During the Evaluation Period
Description
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time Frame
From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)
Title
Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug
Description
Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
Time Frame
From Randomization (Week 1) up to Evaluation Visit (Week 30)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
13
City
Beijing
Country
China
Facility Name
16
City
Changchun City
Country
China
Facility Name
10
City
Chengdu
Country
China
Facility Name
5
City
Chengdu
Country
China
Facility Name
4
City
Chongqing
Country
China
Facility Name
26
City
Guangzhou City
Country
China
Facility Name
11
City
Guangzhou
Country
China
Facility Name
1
City
Guangzhou
Country
China
Facility Name
20
City
Guangzhou
Country
China
Facility Name
24
City
Hangzhou
Country
China
Facility Name
22
City
Harbin
Country
China
Facility Name
29
City
Kunming
Country
China
Facility Name
23
City
Nanjing City
Country
China
Facility Name
6
City
Nanjing City
Country
China
Facility Name
8
City
Nanjing City
Country
China
Facility Name
21
City
Nanjing
Country
China
Facility Name
27
City
Qingdao
Country
China
Facility Name
14
City
Shanghai
Country
China
Facility Name
15
City
Shanghai
Country
China
Facility Name
18
City
Shanghai
Country
China
Facility Name
2
City
Shanghai
Country
China
Facility Name
19
City
Shijiazhuang
Country
China
Facility Name
3
City
Suzhou
Country
China
Facility Name
9
City
Taiyuan
Country
China
Facility Name
25
City
Tianjin
Country
China
Facility Name
12
City
Wuhan
Country
China
Facility Name
7
City
Xi'an
Country
China
Facility Name
17
City
Xian
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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