Refractory EpilepsyNCT04398667
European Non-interventional Study on Refractory Epilepsy With Developmental Delay
An observational study of Refractory Epilepsy and Development Delay, run by Zogenix, Inc. at 19 sites in 4 countries.
Trial summary
This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Refractory Epilepsy, Development Delay
- How many people
- 93 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 14 Mar 2019to 4 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with rare epilepsy syndromes up to the date of the most recent visit at the study site.
Who may be able to join
- 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.
Who cannot join
- Normal cognitive development.
- Any acute symptomatic seizures in participants with underlying developmental delay.
- Any progressive intellectual and neurological deterioration conditions.
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Germany12 sites
Charité - Universitätsmedizin Berlin
Berlin
Institut der Diagnostik der Epilepsien
Berlin
Zentrum für Sozialpädiatrie und Neuropädiatrie (DBZ), Vivantes Klinikum
Berlin
Gesellschaft für Epilepsieforschung e. V.
Bielefeld
Klinik für Epileptologie, Universitätsklinikum Bonn
Bonn
Klinik für Neurologie, Heilig Geist-Krankenhaus GmbH
Cologne
Klinik Für Kinder- und Jugendmedizin, Neuropadiatrie und Epilepsiezentrum
Frankfurt
Department of Neurology / Epileptology, University Medicine Greifswald
Greifswald
Klinik für Kinder-und Jugendmedizin II, Universitätsklinikum Schleswig-Holstein
Kiel
Epilepsiezentrum Kork
Kork
Department of Neurologie University of Magdeburg
Magdeburg
Abteilung für Epileptologie, ZfP Südwürttemberg
Ravensburg
France3 sites
Unité de neuropédiatrie, CHU Angers
Angers
Department of Neurology - Foundation John Bost
La Force
Hospital St Louis DRCI, CHU Bicêtre
Paris
Spain2 sites
Hospital Vall d'Hebron
Barcelona
Hospital Ruber Internacional
Madrid
About this study
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
This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).
Read the 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.
- Conditions
- Refractory Epilepsy, Development Delay
- Keywords
- Observational, Retrospective
- Medical subject headings
- Drug Resistant Epilepsy, Learning Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With and Without Diagnosis of an Epilepsy Syndrome
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/
Measured: 5 months
Understand the Clinical Practice Criteria
Understand the clinical practice criteria used for specific syndromic diagnosis of participants with refractory epilepsy associated with developmental delay.
Measured: 5 months
Clinical Practice Diagnostic Criteria Compared to ILAE
Compare clinical practice diagnostic criteria to those proposed by the ILAE and identify potential areas of educational need.
Measured: 5 months
Understand the Time to Formal Diagnosis
Understand the time to diagnosis, from first seizure to formal diagnosis of a specific syndrome.
Measured: 5 months
Unclassified Epilepsy
Evaluate if unclassified epilepsy can be grouped with common electroclinical phenotype features.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start14 Mar 2019
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Why it stopped: The clinical research organization went out of business.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398667
- Sponsor's protocol ID
- 915-ENSURED
- Status last verified
- Nov 2023
- First submitted
- 18 May 2020
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04398667
- Acronym / sponsor ID
- 915-ENSURED
- Conditions
- Refractory Epilepsy, Development Delay
- Keywords
- Observational, Retrospective
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The clinical research organization went out of business.
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with rare epilepsy syndromes up to the date of the most recent visit at the study site.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Normal cognitive development.
- Any acute symptomatic seizures in participants with underlying developmental delay.
- Any progressive intellectual and neurological deterioration conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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.
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.
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.
Results and safety
The study was stopped early (reason given: The clinical research organization went out of business.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Epilepsy and Development Delay, run by Zogenix, Inc. at 19 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, France, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The clinical research organization went out of business.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With and Without Diagnosis of an Epilepsy Syndrome (time frame: 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.