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

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    Zogenix, Inc.
Send
Updated on 5 August 2020
See if I qualify
developmental delay
intellectual disability
epilepsy
seizure
antiepileptic

Summary

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

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.

Details
Condition Epilepsy, Epilepsy, Development Delay
Age 2years - 100years
Clinical Study IdentifierNCT04398667
SponsorZogenix, Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

developmental delay
intellectual disability
epilepsy
seizure
antiepileptic

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.