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

UCB

Status and phase

Completed

Phase 2

Conditions

Epilepsy

Treatments

Drug: Levetiracetam

Study type

Interventional

Funder types

Industry

Identifiers

NCT00535392

N01274

2006-005722-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

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