A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

Study Overview
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Brief Summary
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A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.

Official Title
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A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)

Conditions
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Epilepsies, Partial

Intervention / Treatment
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* Drug: Levetiracetam 250 mg
* Drug: Levetiracetam 500 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epileptic patients who fulfill the following criteria are eligible for inclusion in the study: Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to Clinical and electroencephalographic classification of epileptic seizures (1981) defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks Exclusion Criteria: The following patients are not eligible for inclusion into the study: Subjects who were diagnosed with status epilepticus within 3 months before screening Subjects with no partial seizures of which frequency was measured during the Baseline Period Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study Subjects with a history of oral treatment with Levetiracetam (LEV)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lev 0.5 g<br>Levetiracetam 0.5 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). | Drug: Levetiracetam 250 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 250 mg Route of Administration: Oral Use<br>* Other names: Keppra;|
| Experimental: Lev 1 g<br>Levetiracetam 1 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). | Drug: Levetiracetam 250 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 250 mg Route of Administration: Oral Use<br>* Other names: Keppra;Drug: Levetiracetam 500 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 500 mg Route of Administration: Oral Use<br>* Other names: Keppra;|
| Experimental: Lev 2 g<br>Levetiracetam 2 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). | Drug: Levetiracetam 250 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 250 mg Route of Administration: Oral Use<br>* Other names: Keppra;Drug: Levetiracetam 500 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 500 mg Route of Administration: Oral Use<br>* Other names: Keppra;|
| Experimental: Lev 3 g<br>Levetiracetam 3 g/day as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). | Drug: Levetiracetam 250 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 250 mg Route of Administration: Oral Use<br>* Other names: Keppra;Drug: Levetiracetam 500 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 500 mg Route of Administration: Oral Use<br>* Other names: Keppra;|
| Placebo Comparator: Placebo<br>Placebo tablets as add-on therapy to ongoing treatment with 1 to 3 AED(s) administered orally twice daily (in the morning and evening). | Other: Placebo<br>* Active Substance: Placebo Pharmaceutical Form: Film-coated tablet Concentration: 250 mg and 500 mg Route of Administration: Oral Use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period |  | From Baseline to the 12-week Evaluation Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial (Type I) seizure frequency per week over the Evaluation Period |  | 12-week Evaluation Period | 
| Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period |  | From Baseline to the 12-week Evaluation Period | 
| Seizure freedom over the Evaluation Period |  | 12-week Evaluation Period | 
| Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period |  | From Baseline to the 12-week Evaluation Period | 
| Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period |  | From Baseline to the 12-week Evaluation Period | 

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