Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
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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 4 to 16 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 (4 - 16 Years Old) With Epilepsy. |
- 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 ]
- 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) ] [ 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: | 33 |
| Study Start Date: | September 2007 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 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. 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:
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Show 25 Study Locations| 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: | NCT00535392 History of Changes |
| Other Study ID Numbers: | N01274, 2006-005722-23 |
| Study First Received: | September 25, 2007 |
| Results First Received: | January 28, 2011 |
| Last Updated: | August 30, 2011 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Germany: Federal Institute for Drugs and Medical Devices 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 June 18, 2013