Back to resultsAn Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
Primary Purpose
Epilepsy, Partial Onset Seizures
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Levetiracetam (LEV)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Subject is male or female and aged ≥ 16 years at Visit 1
- Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
- Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
- Minimum body weight of 40 kg at Visit 1
Exclusion Criteria:
- Subject has a history or presence of seizure types other than partial (IA, IB, IC)
- Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
- Subject has a history or presence of known Pseudo-Seizures
- Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
- Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Sites / Locations
- 19
- 33
- 21
- 12
- 14
- 11
- 30
- 8
- 20
- 17
- 3
- 26
- 9
- 32
- 25
- 5
- 4
- 22
- 24
- 15
- 27
- 13
- 1
- 29
- 2
- 7
- 18
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Levetiracetam 1000 mg/day to 2000 mg/day group
Levetiracetam 3000 mg/day group
Arm Description
Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP.
Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period. They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period. The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP.
Outcomes
Primary Outcome Measures
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
A documented seizure during 6 consecutive months of the Evaluation Analysis Period
Subject discontinued the study prematurely during the Evaluation Analysis Period
Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Secondary Outcome Measures
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
A documented seizure during 6 consecutive months of the Evaluation Analysis Period
Subject discontinued the study prematurely during the Evaluation Analysis Period
Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.
Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve.
Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve.
Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01506882
Brief Title
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
Official Title
An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Japan Co. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam 1000 mg/day to 2000 mg/day group
Arm Type
Experimental
Arm Description
Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1- week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day.
The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP.
Arm Title
Levetiracetam 3000 mg/day group
Arm Type
Experimental
Arm Description
Unless a seizure occurs, the subjects in this arm will continue LEV 3000 mg/day for 26 weeks. Subjects in the LEV 3000 mg/day group undergo a 4-week Up-Titration Period prior to the 1-week Stabilization Period.
They receive 1000 mg/day for 2 weeks and 2000 mg/day for 2 weeks during the Up-Titration Period and LEV 3000 mg/day for 1 week during the Stabilization Period.
The LEV dose could be decreased as a fallback option at the investigator's discretion, if the subject did not tolerate the LEV dosage, as evidenced by the development of an AE. The fallback option was permitted to be performed once for subjects on LEV 2000 mg/day at any time during the restarted Stabilization Period (SP), restarted Evaluation Period (EP), or Maintenance Period (MP), as well as for subjects on LEV 3000 mg/day at any time during the SP, EP, or MP.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam (LEV)
Other Intervention Name(s)
Keppra, E Keppra
Intervention Description
Active Substance: Levetiracetam
Pharmaceutical Form: Film-coated tablet
Concentration: LEV 250 mg, LEV 500 mg
Frequency: Twice daily
Route of Administration: Oral use
Primary Outcome Measure Information:
Title
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Description
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
A documented seizure during 6 consecutive months of the Evaluation Analysis Period
Subject discontinued the study prematurely during the Evaluation Analysis Period
Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Time Frame
From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Secondary Outcome Measure Information:
Title
Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Description
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.
Time Frame
From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Title
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period
Description
A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:
A documented seizure during 6 consecutive months of the Evaluation Analysis Period
Subject discontinued the study prematurely during the Evaluation Analysis Period
Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.
Time Frame
From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period
Title
Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period
Description
Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.
Time Frame
From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period
Title
Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Description
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve.
Time Frame
During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Title
Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group
Description
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Time Frame
During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
Title
Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Description
Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.
The Median time to first seizure will be estimated from the Kaplan-Meier curve.
Time Frame
During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year
Title
Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group
Description
Median time to withdrawal will be estimated from the Kaplan-Meier curve.
Time Frame
During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male or female and aged ≥ 16 years at Visit 1
Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
Minimum body weight of 40 kg at Visit 1
Exclusion Criteria:
Subject has a history or presence of seizure types other than partial (IA, IB, IC)
Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
Subject has a history or presence of known Pseudo-Seizures
Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
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
19
City
Aomori
Country
Japan
Facility Name
33
City
Asaka
Country
Japan
Facility Name
21
City
Daito
Country
Japan
Facility Name
12
City
Fujisawa
Country
Japan
Facility Name
14
City
Hamamatsu
Country
Japan
Facility Name
11
City
Himeji
Country
Japan
Facility Name
30
City
Hirosaki
Country
Japan
Facility Name
8
City
Kagoshima
Country
Japan
Facility Name
20
City
Kamakura
Country
Japan
Facility Name
17
City
Kawasaki
Country
Japan
Facility Name
3
City
Kitakyusyu
Country
Japan
Facility Name
26
City
Kodaira
Country
Japan
Facility Name
9
City
Kokubunji
Country
Japan
Facility Name
32
City
Kyoto
Country
Japan
Facility Name
25
City
Miyakonojo
Country
Japan
Facility Name
5
City
Nagoya Aichi
Country
Japan
Facility Name
4
City
Nara
Country
Japan
Facility Name
22
City
Okayama
Country
Japan
Facility Name
24
City
Osakasayama
Country
Japan
Facility Name
15
City
Osaka
Country
Japan
Facility Name
27
City
Osaka
Country
Japan
Facility Name
13
City
Saitama
Country
Japan
Facility Name
1
City
Sakai
Country
Japan
Facility Name
29
City
Sapporo
Country
Japan
Facility Name
2
City
Toyonaka
Country
Japan
Facility Name
7
City
Ube
Country
Japan
Facility Name
18
City
Yamagata
Country
Japan
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
An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy
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