Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

Study Overview
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Brief Summary
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To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.

Official Title
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An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Keppra XR (Levetiracetam XR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who were randomized into study N01280 [NCT00419094], and completed the 2 week up titration period Exclusion Criteria: Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094] Subjects who were discontinued prior to the end of titration period

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keppra XR (Levetiracetam XR)<br>1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years) | Drug: Keppra XR (Levetiracetam XR)<br>* 500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).<br>* Other names: Keppra XR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Duration of the Treatment Period (6 months-2 years) | 
| Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years) | A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention. | Duration of the Treatment Period (6 months-2 years) | 
| Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period | An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Duration of the Treatment Period (6 months-2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months | Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 6 months. | Study entry through 6 months | 
| Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months | Among subjects in the Efficacy (EFF) population entering the study on Keppra XR monotherapy and exposed for at least 6 months, is the percentage of subjects remaining on monotherapy treatment for at least 12 months. | Study entry through 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keppra XR, Levetiracetam XR, long term, partial seizures