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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00505934
First received: July 20, 2007
Last updated: August 30, 2011
Last verified: March 2011
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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, Inc.:

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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received [ Time Frame: Treatment period (up to 4 days) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Month to 4 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00505934     History of Changes
Other Study ID Numbers: N01275, 2007-003517-13
Study First Received: July 20, 2007
Results First Received: January 28, 2011
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Mexico: Federal Commission for Protection Against Health Risks
Turkey: Ministry of Health

Keywords provided by UCB, Inc.:
Epilepsy
Child
Levetiracetam
Keppra®
Infusion
Intravenous

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

ClinicalTrials.gov processed this record on April 14, 2014