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Recruiting NCT05126914

Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents

Observational Epilepsy West Syndrome Dravet Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Epilepsy, West Syndrome, Dravet Syndrome. Basic parameters: up to 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention. The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations. As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.

Primary outcome measures

  • rate of decrease in epileptic seizures [Time frame: 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 11 centers
  • CHU Angers — Angers
  • CHU de Bordeaux — Bordeaux
  • CHU de Brest - Hôpital de la Cavale Blanche — Brest
  • CHRU Lille — Lille
  • HFME - HospiceS Civils De Lyon — Lyon
  • Hôpital La Timone - APHM — Marseille
  • Hôpital Necker - APHP — Paris
  • Hopital Robert Debré - Neurologie — Paris
  • … and 3 more centers

Identifiers

NCT: NCT05126914 · P210776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗