European Non-interventional Study on Refractory Epilepsy With Developmental Delay

Refractory Epilepsy Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Development Delay
• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

• NCT number: NCT04398667
• Study type: Observational
• Source: UCB Pharma
• Status: Terminated
• Start date: March 14, 2019
• Completion date: September 4, 2020