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Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
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 Epilepsy focused on measuring Levetiracetam, Keppra

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult
  • in- or out-subjects suffering from partial onset seizures according to the ILAE classification of Epileptic Seizures;
  • intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (AED).

Exclusion Criteria:

  • Had problems of venous accessibility;
  • showed safety issues related to the administration of one of the concomitant AEDs requiring medical intervention;
  • clinically significant ECG/lab abnormalities;
  • administered vigabatrine;
  • administered felbamate for less than 18 months;
  • had contraindication to any component of the study medication treatment as IV formulation or known allergic reaction to or intolerance of pyrrolidone derivatives.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    safety and tolerability of levetiracetam after switching from oral formulation to 15-minute IV infusion during repeated dosing (4 days b.i.d.)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2008
    Last Updated
    December 5, 2013
    Sponsor
    UCB Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00610454
    Brief Title
    Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures
    Official Title
    Trial Evaluating the Safety and Tolerability of Levetiracetam Intravenous 15-minute Infusion, Administered in b.i.d. Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 65 Years Suffering From Partial Onset Seizures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    UCB Pharma

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Subjects receiving LEV as adjunctive therapy to 1 or 2 other AEDs for partial onset seizures and subjects who are temporarily unable to take oral LEV, may require alternative routes of administration. The purpose of this trial was to evaluate the safety and tolerability of 1000 to 3000 mg/day LEV administered as a 15-min IV infusion b.i.d. after switching from the same oral dose.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Levetiracetam
    Primary Outcome Measure Information:
    Title
    safety and tolerability of levetiracetam after switching from oral formulation to 15-minute IV infusion during repeated dosing (4 days b.i.d.)
    Time Frame
    Adverse events after each infusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult in- or out-subjects suffering from partial onset seizures according to the ILAE classification of Epileptic Seizures; intake of levetiracetam as an adjunctive antiepileptic oral treatment in addition to one or two antiepileptic drugs (AED). Exclusion Criteria: Had problems of venous accessibility; showed safety issues related to the administration of one of the concomitant AEDs requiring medical intervention; clinically significant ECG/lab abnormalities; administered vigabatrine; administered felbamate for less than 18 months; had contraindication to any component of the study medication treatment as IV formulation or known allergic reaction to or intolerance of pyrrolidone derivatives.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    UCB Clinical Trial Call Center
    Organizational Affiliation
    +1 877 822 9493 (UCB)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17326794
    Citation
    Baulac M, Brodie MJ, Elger CE, Krakow K, Stockis A, Meyvisch P, Falter U. Levetiracetam intravenous infusion as an alternative to oral dosing in patients with partial-onset seizures. Epilepsia. 2007 Mar;48(3):589-92. doi: 10.1111/j.1528-1167.2006.00959.x. Epub 2007 Feb 22.
    Results Reference
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    Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures

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