ESPERA - European observational study on epileptic patients (Requiring at least two Antiepileptic drugs)
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 09/07/2020 | Version : 1 | ID : 153
| General | |
| Identification | |
| Detailed name | European observational study on epileptic patients (Requiring at least two Antiepileptic drugs) |
| Sign or acronym | ESPERA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 910087 |
| General Aspects | |
| Medical area |
Neurology |
| Health determinants |
Iatrogenic Medicine |
| Keywords | pharmaco-resistance, observational |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | GSK laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals 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. |
A two-stage stratification method will be used to ensure sufficient number of AEDs resistant patients to be enrolled:
a) stratification of the investigators: there are a total number of about 2,000 neurologists in each country of interest. These neurologists can be divided in 3 categories according to the magnitude of their activity in the management of epilepsy : - A first category concerns neurologists with a low activity (less than 5 outpatients a week in consultation) they will not be invited to participate. - A second category concerns neurologists specialised in epilepsy management (epileptologists) who will be identified, either as members of a medical association (French League Against Epilepsy in France) or through their setting in centres specialized in epilepsy (about 20 centres in France and Spain). All epileptologists in this category will be asked to participate. - The third category includes the remaining neurologists. The study will be proposed to a random sample of this last group up to reach the expected number of participating investigators. b) stratification of the patients included: each investigator will be asked to enroll about one AEDs resistant in three patients, the other patients being either patients whose AEDs resistance is currently undefined or AEDs responsive patients. The 3 sub-groups of patients included will therefore be as follows: • AEDs resistant patients in accordance with the criteria established by the ILAE in 2009 (see the note below); • AEDs responsive patient at inclusion; • Status currently undefined regarding AEDs resistance at inclusion According to the 2009 ILAE Task Force definition a AEDs resistance is defined as “failure of adequate trials of two tolerated appropriately chosen and used AEDs schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom”. The seizure freedom is defined by “freedom from all types of seizures for 12 months or 3 times the preintervention interseizure interval, whichever is longer” |
| Database objective | |
| Main objective | To describe the population of adult patients with focal epilepsy currently being treated by an association of at least two antiepileptic medications, in terms of clinical profile, current medical management and seizure control, history of care, referral pathways and quality of life. |
| Inclusion criteria |
• Patient aged ≥ 18 years, presenting with focal epilepsy with or without secondary generalization;
• Patient currently treated with at least 2 antiepileptic medications in association, for at least 3 months, whether the patient is seizure-free or not; • Available medical data allowing to specify AEDs responsiveness status (resistant, responsive, or undefined); • Patient who has agreed to participate after having read the information letter. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France and Spain |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 800 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | The data collected will circulate from the investigators to the data management center via a depersonalized paper questionnaire (medical data). The other data collected will circulate from the patients to the data management center via the depersonalized paper questionnaires (self-questionnaires) sent through the mail (return postage paid envelope). |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
