Clinical trial NCT00535392: Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
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.
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: 2007-09-26
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
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 4 to 16 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 (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 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.

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 40 mg/kg/Day) 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: La Jolla
country: United States
state: California
city: Boston
country: United States
state: Massachusetts
city: Chesterfield
country: United States
state: Missouri
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: Milwaukee
country: United States
state: Wisconsin
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Amiens
country: France
city: Lille
country: France
city: Paris
country: France
city: Heidelberg
country: Germany
city: Kehl
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: