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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00505934
First Posted: July 25, 2007
Last Update Posted: July 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
  Purpose
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.

Condition Intervention Phase
Epilepsy Drug: Levetiracetam Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy

Resource links provided by NLM:


Further study details as provided by UCB Pharma ( UCB Pharma SA ):

Primary Outcome Measures:
  • 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 Measures:
  • 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) ]
  • Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received [ Time Frame: Treatment period (up to 4 days) ]

Enrollment: 19
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505934


Locations
United States, California
San Diego, California, United States
United States, New York
Buffalo, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Fort Worth, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Belgium
Gent, Belgium
Leuven, Belgium
France
Amiens, France
Lille, France
Paris, France
Vandoeuvre Les Nancy, France
Germany
Heidelberg, Germany
Kehl, Germany
Kiel, Germany
Mexico
Torreon, Coahuila, Mexico
Puebla, CP, Mexico
Aguascalientes, Mexico
Guadalajara, Mexico
Mexico City, Mexico
Puebla, Mexico
Turkey
Ankara, Turkey
Izmir, Turkey
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB Pharma SA
ClinicalTrials.gov Identifier: NCT00505934     History of Changes
Other Study ID Numbers: N01275
2007-003517-13 ( EudraCT Number )
First Submitted: July 20, 2007
First Posted: July 25, 2007
Results First Submitted: January 28, 2011
Results First Posted: February 25, 2011
Last Update Posted: July 15, 2015
Last Verified: June 2015

Keywords provided by UCB Pharma ( UCB Pharma SA ):
Epilepsy
Child
Levetiracetam
Keppra®
Infusion
Intravenous

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs