Phase 2
N=33
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00535392 ↗Enrolled (actual)
33
Serious AEs
9.1%
Results posted
Feb 2011
Primary outcome: Primary: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) — 21 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Levetiracetam (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) |
21 | — |
| SECONDARY 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) |
10 | — |
| SECONDARY Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received |
3.73 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00535392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.