Real-life follow-up of rare epilepsies in children and adolescents
Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents
This project will follow children and teens with rare epilepsies to see how they respond to treatments and how cognitive and psychiatric problems change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 15 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 11 sites (Angers and 10 other locations) |
| Trial ID | NCT05126914 on ClinicalTrials.gov |
What this trial studies
This multicentre, observational follow-up collects real-world data on children and adolescents with rare epileptic syndromes diagnosed using ORPHA codes. The study records treatment responses and the course of cognitive and psychiatric comorbidities during routine care. Data are gathered at declared participating centers in France to help define prognostic factors and inform clinical management. The project also aims to provide real-life outcome measures that could improve endpoints for future therapeutic trials.
Who should consider this trial
Good fit: Children and adolescents with a diagnosed rare epilepsy (per ORPHA codes) who are followed at one of the participating centers and whose parents or guardians do not object are eligible.
Not a fit: Patients not followed at a participating center, adults, or those whose parents or guardians refuse participation are unlikely to benefit directly from this project.
Why it matters
Potential benefit: If successful, it could give families clearer prognoses and help clinicians choose and time treatments based on real-world outcomes.
How similar studies have performed: There are a few randomized trials for some rare epilepsies (for example infantile spasms and Dravet syndrome), but broad real-world longitudinal data across many rare epilepsy syndromes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis for rare epilepsy (based on ORPHA codes) * holders of parental authority not opposed * Be followed in one of the declared centers of the study Exclusion Criteria: * opposition from the holders of parental authority or the patient
Where this trial is running
Angers and 10 other locations
- CHU Angers — Angers, France (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- CHU de Brest - Hôpital de la Cavale Blanche — Brest, France (Recruiting)
- CHRU Lille — Lille, France (Recruiting)
- HFME - HospiceS Civils De Lyon — Lyon, France (Recruiting)
- Hôpital La Timone - APHM — Marseille, France (Recruiting)
- Hôpital Necker - APHP — Paris, France (Recruiting)
- Hopital Robert Debré - Neurologie — Paris, France (Recruiting)
- CHU Strasbourg- Hôpital de Hautepierre — Strasbourg, France (Recruiting)
- Hôpital Purpan - CHU de Toulouse — Toulouse, France (Recruiting)
- CHU de Tours - hôpital Clocheville — Tours, France (Recruiting)
Study contacts
- Study coordinator: Blandine DOZIERES, Dr
- Email: blandine.dozieres@aphp.fr
- Phone: 0140033667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.