Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

Study Overview
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Brief Summary
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For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe. To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

Official Title
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A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female adult subjects (≥ 16 or 18 years) Diagnosis of epilepsy (all types of seizures may be included) Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy Other inclusion criteria may apply Exclusion Criteria: Subjects withdrawn from N01175 (NCT00175903) trial for any reason Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial Subject requiring add-on antiepileptic treatment Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment Sexually active woman with childbearing potential who is not using a medically accepted birth control method

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levetiracetam (LEV)<br> | Drug: Levetiracetam<br>* 500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories). | during open-label therapy phase of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months |  | Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, N01175 (NCT00175903)