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Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Child, Levetiracetam, Keppra®, Infusion, Intravenous

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female between 4 and 16 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 visit 1.
  • The subject is taking felbamate at visit 1 or has been taking it in the past.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levetiracetam

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)

Secondary Outcome Measures

Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received

Full Information

First Posted
September 25, 2007
Last Updated
August 30, 2011
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00535392
Brief Title
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Official Title
Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 4 to 16 years.
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 (4 to 16 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 tablets or oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose. The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam. For children not taking levetiracetam oral tablets or oral solution prior to entering the study: If weight < 50 kg: dose of levetiracetam intravenous (LEV IV) dose will be calculated on the basis of their weight at 20 mg/kg/day (i.e. 10 mg/kg twice daily). If weight ≥ 50 kg: dose of levetiracetam intravenous (LEV IV) will be 1000 mg/day (i.e. 500 mg 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 IV treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
ucb L059, Keppra®
Intervention Description
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. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days)
Time Frame
Treatment period (up to 4 days)
Title
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
Time Frame
Treatment period (up to 4 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female between 4 and 16 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 visit 1. The subject is taking felbamate at visit 1 or has been taking it in the past.
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
Facility Information:
City
La Jolla
State/Province
California
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Chesterfield
State/Province
Missouri
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Brussels
Country
Belgium
City
Gent
Country
Belgium
City
Leuven
Country
Belgium
City
Amiens
Country
France
City
Lille
Country
France
City
Paris
Country
France
City
Heidelberg
Country
Germany
City
Kehl
Country
Germany
City
Torreon
State/Province
Coahuila
Country
Mexico
City
Puebla
State/Province
CP
Country
Mexico
City
Aguascalientes
Country
Mexico
City
Guadalajara
Country
Mexico
City
Mexico City
Country
Mexico
City
Puebla
Country
Mexico
City
Ankara
Country
Turkey
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy

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