Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

June 22, 2015 updated by: UCB Pharma SA

Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy

Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.

The evaluation period was to be considered as one complete set of 4 pharmacokinetic (PK) samples for a maximum of 4 days;

For children already taking levetiracetam oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight:

  • Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily);
  • Children ≥ 6 months to < 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily).

The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.

For children not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dose will correspond to their age and weight as follows:

  • Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily).
  • Children ≥ 6 months to < 4 years: 20 mg/kg/day (i.e. 10 mg/kg twice daily).

However, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.

Subjects were hospitalized for the duration of the levetiracetam intravenous (LEV IV) treatment.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium
      • Leuven, Belgium
  • France
      • Amiens, France
      • Lille, France
      • Paris, France
      • Vandoeuvre Les Nancy, France
  • Germany
      • Heidelberg, Germany
      • Kehl, Germany
      • Kiel, Germany
  • Mexico
      • Aguascalientes, Mexico
      • Guadalajara, Mexico
      • Mexico City, Mexico
      • Puebla, Mexico
    • CP
      • Puebla, CP, Mexico
    • Coahuila
      • Torreon, Coahuila, Mexico
  • Turkey
      • Ankara, Turkey
      • Izmir, Turkey
  • United States
    • California
      • San Diego, California, United States
    • New York
      • Buffalo, New York, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Fort Worth, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between 1 month and 4 years of age, inclusive
  • The subject suffers from epilepsy (except status epilepticus)
  • The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time

Exclusion Criteria:

  • The subject has difficult venous accessibility
  • History of status epilepticus during the 3 months prior to Screening
  • The subject is on felbamate with less than 18 months continuous exposure before Screening.
  • The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levetiracetam
Drug: Levetiracetam

Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).

For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:

  • Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
  • Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Other Names:
  • Keppra®
  • ucb L059

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
Time Frame: Treatment period (up to 4 days)
Treatment period (up to 4 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
Time Frame: Treatment period (up to 4 days)
Treatment period (up to 4 days)
Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)
Time Frame: Treatment period (up to 4 days)
Treatment period (up to 4 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01275
  • 2007-003517-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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