EULEVp - Effectiveness and Use of Levetiracetam of pediatrics in real life ARCHIVE

Head :
Fourrier-Reglat Annie, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen

Last update : 10/26/2017 | Version : 2 | ID : 2831

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Effectiveness and Use of Levetiracetam of pediatrics in real life
Sign or acronym EULEVp
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CCTIRS 07.072, CNIL 904498
General Aspects
Medical area Neurology
Health determinants Iatrogenic
Keywords Levetiracetam, child, effectiveness, prescribing patterns, pharmaco-epidemiology, cohort, Department of Pharmacology, Bordeaux
Scientific investigator(s) (Contact)
Name of the director Fourrier-Reglat
Surname Annie
Address Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex
Phone + 33 (0)5 57 57 46 75
Email annie.fourrier@pharmaco.u-bordeaux2.fr
Unit Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Organization Université Bordeaux
Name of the director Moore
Surname Nicholas
Address Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex
Phone + 33 (0)5 57 57 46 75
Email nicholas.moore@pharmaco.u-bordeaux2.fr
Unit Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Organization Université Bordeaux
Collaborations
Funding
Funding status Mixed
Details Laboratoire UCB Pharma (soutien inconditionnel) - UCB Pharma (unconditional support)
Governance of the database
Sponsor(s) or organisation(s) responsible INSERM
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. This observational study was conducted among a sample of hospital and non-hospital neurologists who were to retrospectively include 250 patients younger than 16 who had a first prescription of levetiracetam between 1 October 2006 and 31 March 2007 and follow these for 12 months from initiation.
Database objective
Main objective The objectives of this study were to describe the children initiating treatment with levetiracetam, the prescribing patterns, and to evaluate the effectiveness of levetiracetam in a real situation in terms of treatment retention for one year.
Inclusion criteria Patient aged under 16 years; Obtainment of consent from the guardian of the child; patient having initiated treatment with levetiracetam between 01/10/2006 and 31/03/2007 (whether or not the treatment was continued), and having never been previously treated with levetiracetam; patient who may be followed over the following 12 months; Patient not participating in a clinical trial (Huriet-Sérusclat).
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Hospital and non-hospital neurologists in metropolitan France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2007
Date of last collection (YYYY or MM/YYYY) 2008
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 156
Data
Database activity Data collection completed
Type of data collected Clinical data
Clinical data (detail) Direct physical measures
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Medicines consumption
Procedures
Data collection method Patients included were the subject of collection of indirectly personal medical data (patient questionnaire completed by the neurologist) at inclusion, at each follow-up visit, and and at one year of follow-up or in case of discontinuation of levetiracetam data will be collected for all patients.
Participant monitoring Yes
Details on monitoring of participants Levetiracetam-treated patients were followed for a period of one year (from date of levetiracetam initiation).
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=eulevp
Description List of publications in Pubmed
Access
Terms of data access (charter for data provision, format of data, availability delay) A final study report was submitted to the funder. The final study report and scientific communications (posters, papers, ...) are validated by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the funder. Terms for third-party access to the database are to be defined.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05