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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05126914
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 15 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Nov 19, 2021
Start date
Dec 11, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

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

Central Contacts

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