Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

UCB

Status: Completed

Conditions: Epilepsy

Study type: Observational

Funder types: Industry

Identifiers

NCT01210690

N01357

2009-017333-21 (EudraCT Number)

Details and patient eligibility

About

The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.

Full description

This non-interventional sentinel sites post-authorization safety study (PASS) aims to collect additional data on use of Keppra® (Levetiracetam) oral solution in clinical practice, and on efficacy and safety of Keppra® (Levetiracetam) in infants younger than12 months. Epileptic patients between the age of 1 month and 11 months inclusive can be invited for participation to the non-interventional sentinel sites PASS, after the physician has decided to initiate therapy with Keppra® (Levetiracetam) oral solution (100 mg/ml bottle) and patient has so far been treated with Keppra® (Levetiracetam) for no longer than 10 days. The patients will be followed and their data will be collected until they reach the age of 13 months.

Enrollment: 101 patients

Sex: All

Ages: 1 to 11 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of epilepsy
• being treated with Keppra® Oral Solution
• aged between 1 month and 11 months inclusive at study baseline

Exclusion criteria

• none

Trial design

101 participants in 1 patient group

Patients, 1 - 11 months old, prescribed Keppra® oral solution

Description:

Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who are between 1 and 11 months old. The patients will be followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, is made independently by the physician in the regular course of practice and is not influenced by the study protocol.