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A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

Primary Purpose

Epilepsies, Partial

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Japan Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsies focused on measuring Epilepsies, Partial, Keppra, levetiracetam

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615] Exclusion Criteria: Female patients during pregnancy, delivery and lactation, or suspected of pregnancy

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levetiracetam

Arm Description

Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Outcomes

Primary Outcome Measures

Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.

Secondary Outcome Measures

Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study
The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as: [ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)
The percent reduction from Baseline was computed as: [ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100. Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Change in simple partial seizure frequency is given as a percent reduction computed as: [ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Change in complex partial seizure frequency is given as a percent reduction computed as: [ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study
Change in secondary generalized seizure frequency is given as a percent reduction computed as: [ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100. Positive values in reduction means the value decreased from Baseline during the first 16-week Period. Secondary generalized seizures belong to one of the 3 groups: Simple partial sz evolving to gen sz Complex partial sz evolving to gen sz Simple partial sz evolving to Complex partial sz evolving to gen sz
Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A): [ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study
Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B): [ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Other types of Seizures are all seizures except Partial Seizures (Type 1).

Full Information

First Posted
August 21, 2006
Last Updated
October 19, 2020
Sponsor
UCB Japan Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00367432
Brief Title
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
Official Title
A Multicenter, Open, Long-term Follow-up Study to Evaluate the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (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
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 [NCT00160165] or N01221 [NCT00280696].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsies, Partial
Keywords
Epilepsies, Partial, Keppra, levetiracetam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Primary Outcome Measure Information:
Title
Occurrence of Treatment-emergent Adverse Events During the Study Period (Until the Time of Approval Granted)
Description
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with the pharmaceutical product. Occurrence of treatment-emergent AEs is reported by the number of subjects with at least one treatment-emergent AE.
Time Frame
During the study period from Visit 1 (Week 0) to the Follow-up Visit (up to Month 60) until the time of approval granted
Secondary Outcome Measure Information:
Title
Change From Baseline in N01221 [NCT00280696] in Partial (Type 1) Seizure Frequency Per Week During the First 16-week Period in This Study
Description
The change in partial (type 1) seizure frequency from Baseline is given as a percent reduction computed as: [ Weekly partial seizure frequency (Baseline)- Weekly partial seizure frequency (Evaluation Period)]/ [Weekly partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Title
Seizure Frequency Per Week in Partial Seizures During the First 16-week Period in This Study
Description
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16)
Title
Response Status (Patients With a Percent Reduction in Partial Seizure Frequency of at Least 50% During the First 16-week Period in This Study From Baseline in N01221)
Description
The percent reduction from Baseline was computed as: [ Weekly seizure frequency (Baseline)- Weekly seizure frequency (Evaluation Period)]/ [Weekly seizure frequency (Baseline)] x 100. Responders are those patients with a percent reduction in partial seizure frequency of at least 50% from Baseline to first Evaluation Period in partial seizure frequency per week. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Title
Change From Baseline in N01221 [NCT00280696] in Simple Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Description
Change in simple partial seizure frequency is given as a percent reduction computed as: [ Weekly simple partial seizure frequency (Baseline)- Weekly simple partial seizure frequency (Evaluation Period)]/ [Weekly simple partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Title
Change From Baseline in N01221 [NCT00280696] in Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Description
Change in complex partial seizure frequency is given as a percent reduction computed as: [ Weekly complex partial seizure frequency (Baseline)- Weekly complex partial seizure frequency (Evaluation Period)]/ [Weekly complex partial seizure frequency (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Title
Change From Baseline in N01221 [NCT00280696] in Secondary Generalized Seizure Frequency Per Week During the First 16-week Period in This Study
Description
Change in secondary generalized seizure frequency is given as a percent reduction computed as: [ Weekly sec. generalized seizure frequency (Baseline)- Weekly sec. generalized seizure frequency (Evaluation Period)]/ [Weekly sec. generalized seizure frequency (Baseline)] x 100. Positive values in reduction means the value decreased from Baseline during the first 16-week Period. Secondary generalized seizures belong to one of the 3 groups: Simple partial sz evolving to gen sz Complex partial sz evolving to gen sz Simple partial sz evolving to Complex partial sz evolving to gen sz
Time Frame
Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Title
Change From Baseline in N01221 [NCT00280696] in Simple and Complex Partial Seizure Frequency Per Week During the First 16-week Period in This Study
Description
Change in simple and complex partial seizure frequency is given as a percent reduction computed as (simple and complex partial seizure frequency := A): [ Weekly A (Baseline)- Weekly A (Evaluation Period)]/ [Weekly A (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.
Time Frame
Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study
Title
Change From Baseline in N01221 [NCT00280696] in Other Types of Seizure Frequency Per Week During the First 16-week Period in This Study
Description
Change in other types of seizure frequency is given as a percent reduction computed as (other types of seizure frequency:= B): [ Weekly B (Baseline)- Weekly B (Evaluation Period)]/ [Weekly B (Baseline)] x 100. Positive values in percent reduction means that the value has decreased from Baseline during the first 16-week Period. Other types of Seizures are all seizures except Partial Seizures (Type 1).
Time Frame
Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who participated in study N01221 [NCT00280696] and completed the evaluation period and transition period or patients who participated in study N01020 [NCT00160615] Exclusion Criteria: Female patients during pregnancy, delivery and lactation, or suspected of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493
Official's Role
Study Director
Facility Information:
City
Aichi-gun
State/Province
Aichi
Country
Japan
City
Nagoya
State/Province
Aichi
Country
Japan
City
Hirosaki
State/Province
Aomori
Country
Japan
City
Matsudo
State/Province
Chiba
Country
Japan
City
Kitakyusyu
State/Province
Fukuoka
Country
Japan
City
Koga
State/Province
Fukuoka
Country
Japan
City
Kurume
State/Province
Fukuoka
Country
Japan
City
Fukuyama
State/Province
Hiroshima
Country
Japan
City
Asahikawa
State/Province
Hokkaido
Country
Japan
City
Hakodate
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Kahoku-gun
State/Province
Ishikawa
Country
Japan
City
Kanazawa
State/Province
Ishikawa
Country
Japan
City
Zentsuji
State/Province
Kagawa
Country
Japan
City
Koshi
State/Province
Kumamoto
Country
Japan
City
Tsu
State/Province
Mie
Country
Japan
City
Iwanuma
State/Province
Miyagi
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Omura
State/Province
Nagasaki
Country
Japan
City
Kashihara
State/Province
Nara
Country
Japan
City
Nagaoka
State/Province
Niigata
Country
Japan
City
Beppu
State/Province
Oita
Country
Japan
City
Izumi
State/Province
Osaka
Country
Japan
City
Neyagawa
State/Province
Osaka
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Takatsuki
State/Province
Osaka
Country
Japan
City
Iruma-gun
State/Province
Saitama
Country
Japan
City
Shimotsuga-gun
State/Province
Tochigi
Country
Japan
City
Shimotsuke
State/Province
Tochigi
Country
Japan
City
Komatsushima
State/Province
Tokushima
Country
Japan
City
Chiyoda-Ku
State/Province
Tokyo
Country
Japan
City
Kodaira
State/Province
Tokyo
Country
Japan
City
Kokubunji
State/Province
Tokyo
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
City
Taito-ku
State/Province
Tokyo
Country
Japan
City
Ube
State/Province
Yamaguchi
Country
Japan
City
Aomori
Country
Japan
City
Chiba
Country
Japan
City
Fukuoka
Country
Japan
City
Fukushima
Country
Japan
City
Gifu
Country
Japan
City
Hiroshima
Country
Japan
City
Kagoshima
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Miyazaki
Country
Japan
City
Niigata
Country
Japan
City
Okayama
Country
Japan
City
Osaka
Country
Japan
City
Shizuoka
Country
Japan
City
Toyama
Country
Japan
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

A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

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