NCT04398667

European Non-interventional Study on Refractory Epilepsy With Developmental Delay

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).

Detailed description

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.

Conditions

• Refractory Epilepsy
• Development Delay

Timeline

• Start date: 2019-03-14
• Primary completion: 2020-09-04
• Completion: 2020-09-04
• First posted: 2020-05-21
• Last updated: 2023-12-01

Locations

19 sites across 4 countries: France, Germany, Italy, Spain