A European Non-interventional Study to Understand the Criteria Used and the Time Required for the Clinical Diagnosis in Participants With Refractory Epilepsies Associated With Developmental Delay
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 19
- 主要终点
- Understand the Clinical Practice Criteria
研究概览
简要总结
This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).
详细描述
This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review). The identified local site staff (or trained independent data abstractors, if requested by the site) will review the medical records of all participants meeting the eligibility criteria, who have provided a signed inform consent form (ICF) for data collection and analysis. For participants who are less than 18 years of age, in addition to the assent form being signed by the participant, an informed consent would be obtained from parental or legally authorized representative.
In line with the retrospective nature of the study: there is no assignment of a participant to a particular therapeutic strategy; no additional diagnostic or monitoring procedures shall be applied to the participants; epidemiological methods shall be used for the analysis of collected data; the prescription of any medication for the treatment of the epileptic syndrome occur before the collection of the data in this study and is clearly separated from the decision to include the participant in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥2 years
- •Disease history of at least 24 months from date of first seizure
- •Medical history of epilepsy associated with moderate to severe intellectual disability, cognitive developmental delay or cognitive regression
- •Medical history of onset of seizures in early childhood (≤ 8 years)
- •Failure of adequate trials of two tolerated and appropriately chosen and used Anti-Epileptic Drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom
- •Ongoing refractory epilepsy
- •MRI and EEG data are available for the participant
- •Participants (or their parents/ legal representative as appropriate) have provided written informed consent / assent form to collect the data specified.
排除标准
- •Normal cognitive development.
- •Any acute symptomatic seizures in participants with underlying developmental delay.
- •Any progressive intellectual and neurological deterioration conditions.
结局指标
主要结局
Understand the Clinical Practice Criteria
时间窗: 5 months
Understand the clinical practice criteria used for specific syndromic diagnosis of participants with refractory epilepsy associated with developmental delay.
Proportion of Participants With and Without Diagnosis of an Epilepsy Syndrome
时间窗: 5 months
Understand the proportion of participants with and without diagnosis of an epilepsy syndrome, as described by the International League Against Epilepsy (ILAE) diagnostic manual located at https://www.epilepsydiagnosis.org/
Understand the Time to Formal Diagnosis
时间窗: 5 months
Understand the time to diagnosis, from first seizure to formal diagnosis of a specific syndrome.
Unclassified Epilepsy
时间窗: 5 months
Evaluate if unclassified epilepsy can be grouped with common electroclinical phenotype features.
Clinical Practice Diagnostic Criteria Compared to ILAE
时间窗: 5 months
Compare clinical practice diagnostic criteria to those proposed by the ILAE and identify potential areas of educational need.
次要结局
未报告次要终点