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 European Non-interventional Study on Refractory Epilepsy with Developmental Delay (ENSURED)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, retrospective data collection (manual Medical Chart Review)

Study drug and medical condition

• Medical condition to be studied:
  Epilepsy

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  To understand the criteria used and the timerequired for the clinical diagnosis in participants with refractory epilepsiesassociated with developmental delay
• Outcomes:
  -Proportion of participants with and without syndromic diagnosis-Criteria used for the diagnosis of clinical syndromes for participants with refractory epilepsy with development delay-Proportion with successful treatment (defined as meaningful clinical response, in clinician’s opinion), if documented in the participant notes.-Time to diagnosis of clinical syndromes for participants
• Data analysis plan:
  This study is a retrospective analysis. For this reason epidemiological methods will be employed for data analyses. All analyses will be performed in an exploratory sense. Since there are no confirmatory analyses planned,hypotheses are not formulated. Data will be analyzed using descriptive statistics. Summaries will be presented by total, age group and country if applicable.