Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy

• ClinicalTrials.gov Identifier: NCT00535392
• Recruitment Status: Completed
• First Posted: September 26, 2007
• Results First Posted: February 25, 2011
• Last Update Posted: August 31, 2011
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

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 4 to 16 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 (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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 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 (4 - 16 Years Old) With Epilepsy.
• Study Start Date: September 2007
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 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. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).; Other Names: ucb L059; Keppra®

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 40 mg/kg/Day) 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: 4 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

La Jolla, California, United States

United States, Massachusetts

Boston, Massachusetts, United States

United States, Missouri

Chesterfield, Missouri, 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

United States, Wisconsin

Milwaukee, Wisconsin, United States

Belgium

Brussels, Belgium

Gent, Belgium

Leuven, Belgium

France

Amiens, France

Lille, France

Paris, France

Germany

Heidelberg, Germany

Kehl, 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

Investigators

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

More Information

Additional Information:

FDA Safety Alerts and Recalls 

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00535392
• Other Study ID Numbers: N01274; 2006-005722-23 ( EudraCT Number )
• First Posted: September 26, 2007
• Results First Posted: February 25, 2011
• Last Update Posted: August 31, 2011
• Last Verified: March 2011

Keywords provided by UCB Pharma:

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

Additional relevant MeSH terms:

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