Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
NCT ID: NCT00535392
Last Updated: 2011-08-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2007-09-30
2010-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levetiracetam
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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La Jolla, California, United States
Boston, Massachusetts, United States
Chesterfield, Missouri, United States
Buffalo, New York, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Richmond, Virginia, United States
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Amiens, , France
Lille, , France
Paris, , France
Heidelberg, , Germany
Kehl, , Germany
Torreón, Coahuila, Mexico
Puebla City, CP, Mexico
Aguascalientes, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Puebla City, , Mexico
Ankara, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2006-005722-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01274
Identifier Type: -
Identifier Source: org_study_id