Application of Novel Diagnostic and Therapeutical Methods in Epilepsy and Neurodevelopmental Abnormalities in Children. (EPIMARKER)
Epilepsy
About this trial
This is an interventional prevention trial for Epilepsy focused on measuring epilepsy, TSC, biomarkers, mTOR pathway
Eligibility Criteria
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:
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Sites / Locations
- Medical University of WarsawRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
Workpackage1 WP1
Workpackage2 WP2
Non interventional trial: 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. We plan to enroll 60 TSC patients into WP1 to Epimarker in 12 months.
Non interventional trial: male or female children with a definite diagnosis of TSC (Roach criteria: Roach 1998) and epilepsy, aged up to 16 years, seizure free, in whom a decision to withdraw antiepileptic drugs was made. We plan to enroll 60 TSC patients into WP2 to Epimarker in 12 months. The data obtained in children seizure free at the end of follow-up and patients with recurrent seizures will be compare.