European Non-interventional Study on Refractory Epilepsy With Developmental Delay.

Sponsor

Zogenix, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04398667

Collaborator

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. (Industry)

1,000

Enrollment

Locations

29.6

Anticipated Duration (Months)

90.9

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Refractory Epilepsy Development Delay

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

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.

Actual Study Start Date :

Mar 14, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Outcome Measures

Primary Outcome Measures

Proportion of Participants With and Without Diagnosis of an Epilepsy Syndrome. [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 Clinical Practice Criteria. [5 months]
Understand the clinical practice criteria used for specific syndromic diagnosis of participants with refractory epilepsy associated with developmental delay.
Clinical Practice Diagnostic Criteria Compared to ILAE. [5 months]
Compare clinical practice diagnostic criteria to those proposed by the ILAE and identify potential areas of educational need.
Understand the Time to Formal Diagnosis. [5 months]
Understand the time to diagnosis, from first seizure to formal diagnosis of a specific syndrome.
Unclassified Epilepsy. [5 months]
Evaluate if unclassified epilepsy can be grouped with common electroclinical phenotype features.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Birmingham Children's Hospital	Birmingham	United Kingdom	B4 6NH
2	Department of Paediatric Neurology, Bristol Royal Hospital for Children	Bristol	United Kingdom	BS2 8AE
3	Paedicatric Neurology Addenbrooke's Hospital	Cambridge	United Kingdom	CB2 0QQ
4	Noah's Ark Children's Hospital for Wales	Cardiff	United Kingdom	CF14 4XW
5	The Alan Richens Welsh Epilepsy Unit, University Hospital of Wales	Cardiff	United Kingdom	CF14 4XW
6	Royal Hospital for Children	Glasgow	United Kingdom	G51 4TF
7	Guys & St Thomas' NHS Foundation Trust, Evelina London Children's Hospital, Paediatric Neurology	London	United Kingdom	SE1 7EH
8	Royal Victoria Infirmary, Newcastle upon Tyne Hospitals	Newcastle Upon Tyne	United Kingdom	NE1 4LP
9	Royal Victoria Infirmary	Newcastle-upon-Tyne	United Kingdom	NE1 4 LP
10	University Hospital Plymouth NHS Trust	Plymouth	United Kingdom	PL6 5DH
11	Ryegate Children's Centre, Sheffield Children's NHS Foundation Trust	Sheffield	United Kingdom	S10 2TH

Sponsors and Collaborators

Zogenix, Inc.
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zogenix, Inc.

ClinicalTrials.gov Identifier:

NCT04398667

Other Study ID Numbers:

915-ENSURED

First Posted:

May 21, 2020

Last Update Posted:

Sep 17, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zogenix, Inc.

Observational

Retrospective

Additional relevant MeSH terms:

Epilepsy

Drug Resistant Epilepsy

Study Results

No Results Posted as of Sep 17, 2020