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

NCT ID: NCT01210690

Last Updated: 2014-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

11 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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012

Amiens, , France

Site Status

010

Bron, , France

Site Status

011

Paris, , France

Site Status

027

Berlin, , Germany

Site Status

024

Bielefeld, , Germany

Site Status

026

Heidelberg, , Germany

Site Status

021

Kehl Kork, , Germany

Site Status

023

Kiel, , Germany

Site Status

022

Münster, , Germany

Site Status

072

Athens, , Greece

Site Status

071

Pátrai, , Greece

Site Status

037

Bologna, , Italy

Site Status

031

Calambrone, , Italy

Site Status

032

Milan, , Italy

Site Status

034

Roma, , Italy

Site Status

035

Verona, , Italy

Site Status

065

Gdansk, , Poland

Site Status

064

Lodz, , Poland

Site Status

063

Szczecin, , Poland

Site Status

062

Warsaw, , Poland

Site Status

043

Barcelona, , Spain

Site Status

044

Madrid, , Spain

Site Status

045

Madrid, , Spain

Site Status

046

Murcia, , Spain

Site Status

057

Birmingham, , United Kingdom

Site Status

052

Liverpool, , United Kingdom

Site Status

051

London, , United Kingdom

Site Status

Countries

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France Germany Greece Italy Poland Spain United Kingdom

Related Links

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

FDA safety Alerts and Recalls

Other Identifiers

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2009-017333-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01357

Identifier Type: -

Identifier Source: org_study_id