Status:
UNKNOWN
Application of Novel Diagnostic and Therapeutical Methods in Epilepsy and Neurodevelopmental Abnormalities in Children.
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Children's Memorial Health Institute, Poland
Conditions:
Epilepsy
Eligibility:
All Genders
1-16 years
Phase:
NA
Brief Summary
Epilepsy affects 1% of the world's population and 6 million people in Europe. The estimated total cost of €20 billion in Europe in 2014 makes epilepsy a significant socioeconomic burden. Despite great...
Detailed Description
The clinical part of EPIMARKER is composed of 2 prospective studies (WP1 and WP2) of epilepsy progress in Tuberous Sclerosis Complex -TSC children, performed in 2 sites: Medical University of Warsaw -...
Eligibility Criteria
Inclusion
- Inclusion Criteria WP1:
- male or female children with a definite diagnosis of TSC (Roach 1998),
- aged up to 4 years,
- diagnosis of epilepsy established on the basis of clinical seizures or
- epileptiform changes on EEG within 1-7 days prior to baseline ,
- written informed consent of caregivers.
- Inclusion Criteria WP2:
- male or female children with a definite diagnosis of TSC (Roach criteria: Roach 1998) with epilepsy,
- aged up to 16 years,
- seizure free, in whom a decision to withdraw antiepileptic drugs was made,
- written informed consent of caregivers.
- Exclusion Criteria:
- \-
Exclusion
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03486366
Start Date
April 1 2017
End Date
March 30 2020
Last Update
April 3 2018
Active Locations (1)
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1
Medical University of Warsaw
Warsaw, Poland, 05-091