A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

Study Overview
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Brief Summary
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This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Official Title
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A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Keppra® extended release formulation - XR
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed diagnosis of refractory epilepsy Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED) Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method Exclusion Criteria: Seizures occurring in clusters Status epilepticus within 3 months of Visit 1 History of non-epileptic seizures Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Keppra® XR<br>Keppra® extended release formulation -XR | Drug: Keppra® extended release formulation - XR<br>* 500mg extended release oral tablet, 2 tablets once daily<br>* Other names: Levetiracetam XR;|
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br>* oral tablets, 2 tablets once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population | Number of POS over the treatment period standardized to 1 week period. | Treatment period (12 weeks) | 
| Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population | Number of POS over the treatment period standardized to 1 week period | Treatment Period (12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POS Seizure Frequency Per Week Over Baseline and Treatment Period |  | Baseline Period (8 weeks) - Treatment Period (12 weeks) | 
| All (Type I+II+III) Seizures Frequency Per Week | Number of All type Seizures over the treatment period standardized to 1 week period (Type I -Partial Onset Seizures, Type II - Generalized Seizures, Type III - Unclassified Epileptic Seizures) | Treatment period (12 weeks) | 
| 50% Response in Weekly POS Frequency | A subject is considered as a 50% responder in POS if he/she has a >= 50% decrease from Baseline in the POS frequency/week over Treatment period. | Treatment period (12 weeks) | 
| Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks | The response is classified according to the percent reduction from baseline in the POS frequency per week over the Treatment Period of 12 weeks duration. | over the treatment period (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Keppra® XR, Levetiracetam XR, Extended release