跳至主要内容
临床试验/NCT05126914
NCT05126914招募中不适用

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

Assistance Publique - Hôpitaux de Paris11 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
11
主要终点
rate of decrease in epileptic seizures

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • opposition from the holders of parental authority or the patient

结局指标

主要结局

rate of decrease in epileptic seizures

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

Loading locations...

相似试验