Status:
TERMINATED
European Non-interventional Study on Refractory Epilepsy With Developmental Delay
Lead Sponsor:
Zogenix, Inc.
Collaborating Sponsors:
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Conditions:
Refractory Epilepsy
Development Delay
Eligibility:
All Genders
2+ years
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 requ...
Eligibility Criteria
Inclusion
- 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
- Normal cognitive development.
- Any acute symptomatic seizures in participants with underlying developmental delay.
- Any progressive intellectual and neurological deterioration conditions.
Key Trial Info
Start Date :
March 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2020
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04398667
Start Date
March 14 2019
End Date
September 4 2020
Last Update
December 1 2023
Active Locations (19)
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1
Unité de neuropédiatrie, CHU Angers
Angers, France
2
Department of Neurology - Foundation John Bost
La Force, France
3
Hospital St Louis DRCI, CHU Bicêtre
Paris, France
4
Charité - Universitätsmedizin Berlin
Berlin, Germany