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

Study Overview
=================
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].

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

Conditions
-----------------
Epilepsies, Partial

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam<br>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). | Drug: Levetiracetam<br>* 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).<br>* Other names: Keppra;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study | 
| 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. | First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 ( Week 16) | 
| 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study | 
| 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study | 
| 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study | 
| 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 | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study | 
| 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. | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study | 
| 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). | Baseline in N01221 [NCT00280696], the First 16-week Evaluation Period from Visit 1 (Week 0) to Visit 5 (Week 16) in this study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsies, Partial, Keppra, levetiracetam