Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

Study Overview
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Brief Summary
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An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

Official Title
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An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures

Conditions
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Generalized Epilepsy

Intervention / Treatment
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* Drug: Levetiracetam 166 mg
* Drug: Levetiracetam 250 mg
* Drug: Levetiracetam 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV) Subjects who were/are suffering from primary generalized (type II) epileptic seizures Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected Exclusion Criteria: Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol Concomitant use of any drug with possible central nervous system effects unless at a stable dose Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 64 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: Levetiracetam<br>Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.). | Drug: Levetiracetam 166 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 166 mg Route of Administration: Oral use<br>Drug: Levetiracetam 250 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 250 mg Route of Administration: Oral use<br>Drug: Levetiracetam 500 mg<br>* Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 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 |
| --- | --- | --- |
| Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period |  | Evaluation Period | 
| Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period |  | Evaluation Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period |  | From Visit 1 to the end of the Evaluation Period | 
| Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period |  | From Visit 1 to the end of the Evaluation Period | 
| Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types |  | From N01057 or N166 Baseline to the Evaluation Period | 
| Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types |  | From N01057 or N166 Baseline to the Evaluation Period | 
| Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations |  | From N01057 or N166 Baseline to the Evaluation Period | 
| Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations |  | From N01057 or N166 Baseline to the Evaluation Period | 
| Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations |  | Evaluation Period | 
| Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types |  | Evaluation Period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Epilepsy, Primary Generalized Seizures, Keppra, Levetiracetam