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

Primary Purpose

Generalized Convulsive Epilepsy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Convulsive Epilepsy focused on measuring Idiopathic Generalized Epilepsy, Myoclonic seizures, Keppra - Levetiracetam

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Responder rate in myoclonic (type IIB) seizures days over 16 weeks

    Secondary Outcome Measures

    Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration

    Full Information

    First Posted
    September 6, 2005
    Last Updated
    September 16, 2013
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00150774
    Brief Title
    Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2001 (undefined)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UCB Pharma

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Generalized Convulsive Epilepsy
    Keywords
    Idiopathic Generalized Epilepsy, Myoclonic seizures, Keppra - Levetiracetam

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    116 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Levetiracetam
    Primary Outcome Measure Information:
    Title
    Responder rate in myoclonic (type IIB) seizures days over 16 weeks
    Secondary Outcome Measure Information:
    Title
    Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    65 Years
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Clinical Trial Call Center
    Organizational Affiliation
    UCB Pharma
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19327967
    Citation
    Rosenfeld WE, Benbadis S, Edrich P, Tassinari CA, Hirsch E. Levetiracetam as add-on therapy for idiopathic generalized epilepsy syndromes with onset during adolescence: analysis of two randomized, double-blind, placebo-controlled studies. Epilepsy Res. 2009 Jul;85(1):72-80. doi: 10.1016/j.eplepsyres.2009.02.016. Epub 2009 Mar 26.
    Results Reference
    result
    PubMed Identifier
    18285535
    Citation
    Noachtar S, Andermann E, Meyvisch P, Andermann F, Gough WB, Schiemann-Delgado J; N166 Levetiracetam Study Group. Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures. Neurology. 2008 Feb 19;70(8):607-16. doi: 10.1212/01.wnl.0000297512.18364.40.
    Results Reference
    result

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

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