Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Study Overview
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Brief Summary
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The safety and efficacy of L059 was evaluated in patients who completed N165 Clinical Trial of L059. They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

Official Title
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Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Conditions
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Epilepsy, Partial

Intervention / Treatment
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* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059 Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients. Exclusion Criteria: Patients who had not participate in N165 Clinical Trial of L059. Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication. Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Ages Eligible for Study
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Minimum Age: 16 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: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam<br>Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509). | Drug: Levetiracetam<br>* Pharmaceutical form: Film-coating tablets Concentration: 250 mg/ 500 mg Route of administration: oral use<br>* Other names: Keppra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial (Type I) Seizure Frequency Per Week by Analysis Visit | Number of Partial (Type I) seizures over the treatment period standardized to 1 week period. | From Baseline up to 54 months | 
| Partial (Type IA) Seizure Frequency Per Week by Analysis Visit | Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period. | From Baseline up to 54 months | 
| Partial (Type IB) Seizure Frequency Per Week by Analysis Visit | Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period. | From Baseline up to 54 months | 
| Partial (Type IC) Seizure Frequency Per Week by Analysis Visit | Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period. | From Baseline up to 54 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit | Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. | From Baseline up to 54 months | 
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit | Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. | From Baseline up to 54 months | 
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit | Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. | From Baseline up to 54 months | 
| Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit | Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period. Negative values indicate improvement from Baseline. | From Baseline up to 54 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, partial, Keppra, Levetiracetam