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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505934
• Other study ID #: N01275
• Secondary ID: 2007-003517-13
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2007
• Last updated: June 22, 2015
• Start date: May 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Mexico: Federal Commission for Protection Against Health RisksTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 4 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma SA

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Mexico,  Turkey, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)		Treatment period (up to 4 days)	No
Secondary	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)		Treatment period (up to 4 days)	No
Secondary	Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received		Treatment period (up to 4 days)	No

External Links

•   FDA Safety Alerts and Links
•   Product Information