European Non-interventional Study on Refractory Epilepsy With Developmental Delay.
European Non-interventional Study on Refractory Epilepsy With Developmental Delay.
This is a multinational, multicentre, non-interventional, retrospective data collection
 (manual Medical Chart Review).
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  Normal cognitive development.

 -  Any acute symptomatic seizures in participants with underlying developmental delay.

 -  Any progressive intellectual and neurological deterioration conditions.