Phase 2
Completed N=19
Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
Source: ClinicalTrials.gov NCT00505934 ↗Enrolled (actual)
19
Serious AEs
21.1%
Results posted
Feb 2011
Primary outcomePrimary: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) — 12 Subjects
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 1 month to 4 years.
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) |
12 | — |
| SECONDARY 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) |
6 | — |
| SECONDARY Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received |
2.89 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female between 1 month and 4 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 Screening
- The subject is on felbamate with less than 18 months continuous exposure before Screening.
- The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.
Data sourced from ClinicalTrials.gov (NCT00505934). 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. Informational only — not medical advice.