Skip to main content
Clinical Trials/NCT05126914
NCT05126914RecruitingNot Applicable

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

Assistance Publique - Hôpitaux de Paris11 sites in 1 country1,000 target enrollmentStarted: December 11, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,000
Locations
11
Primary Endpoint
rate of decrease in epileptic seizures

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

rate of decrease in epileptic seizures

Time Frame: 5 years

rate of decrease in epileptic seizures according to the treatments used based on the seizure calendar kept by the parents as part of the current care.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (11)

Loading locations...

Similar Trials