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

Primary Purpose

Generalized Epilepsy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levetiracetam 166 mg
Levetiracetam 250 mg
Levetiracetam 500 mg
Sponsored by
UCB Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Epilepsy focused on measuring Generalized Epilepsy, Primary Generalized Seizures, Keppra, Levetiracetam

Eligibility Criteria

4 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Levetiracetam

    Arm Description

    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.).

    Outcomes

    Primary Outcome Measures

    Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
    Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

    Secondary Outcome Measures

    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
    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
    Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
    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
    Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
    Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

    Full Information

    First Posted
    September 6, 2005
    Last Updated
    July 28, 2020
    Sponsor
    UCB Pharma SA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00150748
    Brief Title
    Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2001 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    UCB Pharma SA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Generalized Epilepsy
    Keywords
    Generalized Epilepsy, Primary Generalized Seizures, Keppra, Levetiracetam

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    217 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levetiracetam
    Arm Type
    Experimental
    Arm Description
    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.).
    Intervention Type
    Drug
    Intervention Name(s)
    Levetiracetam 166 mg
    Intervention Description
    Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 166 mg Route of Administration: Oral use
    Intervention Type
    Drug
    Intervention Name(s)
    Levetiracetam 250 mg
    Intervention Description
    Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 250 mg Route of Administration: Oral use
    Intervention Type
    Drug
    Intervention Name(s)
    Levetiracetam 500 mg
    Intervention Description
    Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 500 mg Route of Administration: Oral use
    Primary Outcome Measure Information:
    Title
    Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
    Time Frame
    Evaluation Period
    Title
    Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
    Time Frame
    Evaluation Period
    Secondary Outcome Measure Information:
    Title
    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
    Time Frame
    From Visit 1 to the end of the Evaluation Period
    Title
    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
    Time Frame
    From Visit 1 to the end of the Evaluation Period
    Title
    Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    Time Frame
    From N01057 or N166 Baseline to the Evaluation Period
    Title
    Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    Time Frame
    From N01057 or N166 Baseline to the Evaluation Period
    Title
    Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
    Time Frame
    From N01057 or N166 Baseline to the Evaluation Period
    Title
    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
    Time Frame
    From N01057 or N166 Baseline to the Evaluation Period
    Title
    Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations
    Time Frame
    Evaluation Period
    Title
    Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types
    Time Frame
    Evaluation Period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Clinical Trial Call Center
    Organizational Affiliation
    +1 877-822-9493
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22050371
    Citation
    Delanty N, Jones J, Tonner F. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: open-label, noncomparative, multicenter, long-term follow-up study. Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011 Nov 2.
    Results Reference
    derived

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

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