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Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice
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.
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
012
Amiens, France
010
Bron, France
011
Paris, France
027
Berlin, Germany
024
Bielefeld, Germany
026
Heidelberg, Germany
021
Kehl Kork, Germany
023
Kiel, Germany
022
Münster, Germany
072
Athens, Greece
Start Date
January 1, 2011
Primary Completion Date
November 1, 2013
Completion Date
November 1, 2013
Last Updated
November 19, 2014
101
ACTUAL participants
Lead Sponsor
UCB Pharma
NCT06700356
NCT02531880
NCT05871372
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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