Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults

Study Overview
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Brief Summary
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A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.

Official Title
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A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam (LEV) (Oral Tablets of 500 mg b.i.d.) at a Dose of 3000 mg/Day as Adjunctive Treatment in Adolescents (≥ 12 Years) and Adults (≤ 65 Years) Suffering From Idiopathic Generalized Epilepsy With Myoclonic Seizures.

Conditions
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Generalized Convulsive Epilepsy

Intervention / Treatment
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* Drug: Levetiracetam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic- clonic seizures on awakening must be included. Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period. Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period. Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1. Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit 1. Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1. Exclusion Criteria: Previous exposure to levetiracetam. History of partial seizures. History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1. Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet. Subject taking any drug (except the concomitant AEDs) with possible CNS effects.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate in myoclonic (type IIB) seizures days over 16 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Generalized Epilepsy, Myoclonic seizures, Keppra - Levetiracetam