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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractory Epilepsy
- Sponsor
- Zogenix, Inc.
- Enrollment
- 93
- Locations
- 19
- Primary Endpoint
- Understand the Clinical Practice Criteria
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Understand the Clinical Practice Criteria
Time Frame: 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
Time Frame: 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
Time Frame: 5 months
Understand the time to diagnosis, from first seizure to formal diagnosis of a specific syndrome.
Unclassified Epilepsy
Time Frame: 5 months
Evaluate if unclassified epilepsy can be grouped with common electroclinical phenotype features.
Clinical Practice Diagnostic Criteria Compared to ILAE
Time Frame: 5 months
Compare clinical practice diagnostic criteria to those proposed by the ILAE and identify potential areas of educational need.