Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
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|ClinicalTrials.gov Identifier: NCT00505934|
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : February 25, 2011
Last Update Posted : July 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Levetiracetam||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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:.
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
- 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) ]
- 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) ]
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
|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|
|Vandoeuvre Les Nancy, France|
|Torreon, Coahuila, Mexico|
|Puebla, CP, Mexico|
|Mexico City, Mexico|
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|