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

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ClinicalTrials.gov Identifier: NCT00535392
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : February 25, 2011
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 25, 2007
First Posted Date  ICMJE September 26, 2007
Results First Submitted Date  ICMJE January 28, 2011
Results First Posted Date  ICMJE February 25, 2011
Last Update Posted Date August 31, 2011
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2011)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2007)
To asses the pharmacokinetics of levetiracetam in children with epilepsy, in the age range of 4 to 16 years. Plasma and/or saliva samples will be taken at scheduled time-points for levetiracetam determination.
Change History Complete list of historical versions of study NCT00535392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2011)
  • 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) ]
  • Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received [ Time Frame: Treatment period (up to 4 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2007)
Safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Official Title  ICMJE Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (4 - 16 Years Old) With Epilepsy.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE 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.

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).

Other Names:
  • ucb L059
  • Keppra®
Study Arms  ICMJE Experimental: Levetiracetam
Intervention: Drug: Levetiracetam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2010)
33
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2007)
30
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Mexico,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00535392
Other Study ID Numbers  ICMJE N01274
2006-005722-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP