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

NCT ID: NCT00505934

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-03-31

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levetiracetam

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Keppra®; ucb L059

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

San Diego, California, United States

Buffalo, New York, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

Fort Worth, Texas, United States

Richmond, Virginia, United States

Ghent, , Belgium

Leuven, , Belgium

Amiens, , France

Lille, , France

Paris, , France

Vandœuvre-lès-Nancy, , France

Heidelberg, , Germany

Kehl, , Germany

Kiel, , Germany

Torreón, Coahuila, Mexico

Puebla City, CP, Mexico

Aguascalientes, , Mexico

Guadalajara, , Mexico

Mexico City, , Mexico

Puebla City, , Mexico

Ankara, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Countries

United States; Belgium; France; Germany; Mexico; Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 23533164 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Links

Other Identifiers

2007-003517-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01275

Identifier Type: -

Identifier Source: org_study_id