Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

• ClinicalTrials.gov Identifier: NCT00505934
• Recruitment Status: Completed
• First Posted: July 25, 2007
• Results First Posted: February 25, 2011
• Last Update Posted: July 15, 2015
• Sponsor: UCB Pharma SA
• Information provided by (Responsible Party): UCB Pharma ( UCB Pharma SA )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Epilepsy	Drug: Levetiracetam	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 2008
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm

Intervention/treatment

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 within the following dose range, calculated on the basis of their age and weight:.; Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);; Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily). For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows: Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).; Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).; Other Names: Keppra®; ucb L059

Outcome Measures

Primary Outcome Measures :

1. 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) ]

Secondary Outcome Measures :

1. 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) [ Time Frame: Treatment period (up to 4 days) ]
2. Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received [ Time Frame: Treatment period (up to 4 days) ]

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 4 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

San Diego, California, United States

United States, New York

Buffalo, New York, United States

United States, Pennsylvania

Philadelphia, Pennsylvania, United States

United States, Tennessee

Nashville, Tennessee, United States

United States, Texas

Fort Worth, Texas, United States

United States, Virginia

Richmond, Virginia, United States

Belgium

Gent, Belgium

Leuven, Belgium

France

Amiens, France

Lille, France

Paris, France

Vandoeuvre Les Nancy, France

Germany

Heidelberg, Germany

Kehl, Germany

Kiel, Germany

Mexico

Torreon, Coahuila, Mexico

Puebla, CP, Mexico

Aguascalientes, Mexico

Guadalajara, Mexico

Mexico City, Mexico

Puebla, Mexico

Turkey

Ankara, Turkey

Izmir, Turkey

Sponsors and Collaborators

UCB Pharma SA

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Links 

Publications of Results:

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.

• Responsible Party: UCB Pharma SA
• ClinicalTrials.gov Identifier: NCT00505934
• Other Study ID Numbers: N01275; 2007-003517-13 ( EudraCT Number )
• First Posted: July 25, 2007
• Results First Posted: February 25, 2011
• Last Update Posted: July 15, 2015
• Last Verified: June 2015

Keywords provided by UCB Pharma ( UCB Pharma SA ):

Epilepsy; Child; Levetiracetam; Keppra®; Infusion; Intravenous

Additional relevant MeSH terms:

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Levetiracetam; Anticonvulsants; Nootropic Agents