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