Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex

Summary

The primary objective of clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC.

Secondary objective of the clinical part of EPISTOP is to compare the effects of standard antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.

Conditions

• TSC
• Tuberous Sclerosis Complex
• Epilepsy

Interventions

DEVICE

epilepsy early diagnosis protocol

Infants that have epileptiform discharges on vEEG and no clinical seizures, if their parents/caregivers give consent, will enter the randomized part of the study. Those children will be randomized into two groups: group A will be diagnosed as having epilepsy after subclinical (electroencephalographic) epileptiform discharges (based on epilepsy early diagnosis protocol), and the patients in group B will be diagnosed as epileptic after clinical seizures appear. All infants diagnosed with epilepsy will receive standard therapy with recommended first line antiepileptic drug starting from the day of diagnosis.

Sponsors & Collaborators

• University of Rome Tor Vergata

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Vrije Universiteit Brussel

  collaborator OTHER

• General University Hospital, Prague

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Rudolf Magnus Institute - University of Utrecht

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Sergiusz Jozwiak

  lead OTHER

Principal Investigators

• Seriusz Jozwiak, Md, PhD · Children's Memorial Health Institute

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

4 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2018-10-31

Completion

2018-10-31

Countries

• Austria
• Belgium
• Czechia
• France
• Germany
• Italy
• Netherlands
• Poland

Study Locations