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
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|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 (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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 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 (4 - 16 Years Old) With Epilepsy.|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 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.
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).
- 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 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) ]
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|Ages Eligible for Study:||4 Years to 16 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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): NCT00535392
|United States, California|
|La Jolla, California, United States|
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|United States, Missouri|
|Chesterfield, Missouri, 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|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States|
|Torreon, Coahuila, Mexico|
|Puebla, CP, Mexico|
|Mexico City, Mexico|
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|
|Responsible Party:||UCB Pharma|
|Other Study ID Numbers:||
2006-005722-23 ( EudraCT Number )
|First Posted:||September 26, 2007 Key Record Dates|
|Results First Posted:||February 25, 2011|
|Last Update Posted:||August 31, 2011|
|Last Verified:||March 2011|
Central Nervous System Diseases
Nervous System Diseases