Clinical trial NCT00505934: Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
Official title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Epilepsy
Child
Levetiracetam
Keppra®
Infusion
Intravenous
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 (1 month to 4 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 solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight:

* Children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily);
* Children ≥ 6 months to \< 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily).

The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.

For children not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dose will correspond to their age and weight as follows:

* Children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily).
* Children ≥ 6 months to \< 4 years: 20 mg/kg/day (i.e. 10 mg/kg 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 intravenous (LEV IV) treatment.

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.

Primary outcomes:
measure: Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
timeFrame: Treatment period (up to 4 days)
Secondary outcomes:
measure: 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)
timeFrame: Treatment period (up to 4 days)
measure: Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
timeFrame: Treatment period (up to 4 days)
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Buffalo
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Amiens
country: France
city: Lille
country: France
city: Paris
country: France
city: Vandoeuvre Les Nancy
country: France
city: Heidelberg
country: Germany
city: Kehl
country: Germany
city: Kiel
country: Germany
city: Torreon
country: Mexico
state: Coahuila
city: Puebla
country: Mexico
state: CP
city: Aguascalientes
country: Mexico
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Puebla
country: Mexico
city: Ankara
country: Turkey
city: Izmir
country: Turkey
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Weinstock A, Ruiz M, Gerard D, Toublanc N, Stockis A, Farooq O, Dilley D, Karmon Y, Elgie MJ, Schiemann-Delgado J. Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy. J Child Neurol. 2013 Nov;28(11):1423-1429. doi: 10.1177/0883073813480241. Epub 2013 Mar 26.