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