ong-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy - Tuberous Sclerosis Complex.
- Conditions
- EpilepsyTuberous Sclerosis Complex10039911
- Registration Number
- NL-OMON41140
- Lead Sponsor
- Instytut Pomnik-Centrum Zdrowia Dziecka (IPCZD)/ The Children's Memorial Health Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- Male or female infants with a definite diagnosis of TSC (Roach criteria; Roach 1998, or DNA confirmed);
- Age up to 4 months at the moment of enrolment;
- No clinical seizures seen by caregivers or on baseline videoEEG recording;
- Written informed consent of caregivers. It is possible to give consent for the observational part of the study only. In this case, the child will not enter the RCT.
- Any type of seizures observed till baseline visit;
- Antiepileptic treatment at or prior to study entry;
- Contraindications to MRI;
- Any severe and/or uncontrolled medical condition that is considered by the investigator as possibly affecting the EPISTOP analyses or procedures. For example non TSC related malformation of brain development or acquired brain damage.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter is the assessment of (a set of) molecular and clinical<br /><br>biomarkers in full analysis set of patients. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary parameter is the efficacy and safety of preventative<br /><br>antiepileptic treatment in patients diagnosed with epilepsy after epileptiform<br /><br>discharges (group A) in comparison to patients diagnosed with epilepsy after<br /><br>the onset of clinical seizures (including both patients in group B as well as<br /><br>patients who presented with clinical seizures after inclusion but before EEG<br /><br>abnormalities were seen). The parameters of efficacy assessment include: the<br /><br>distribution of seizure free patients, proportion of patients with drug<br /><br>resistant seizures, proportion of patients with normalized EEG, the<br /><br>neurodevelopmental outcome recognized as the results in a battery of<br /><br>neuropsychologiscal tests performed at the age of 24 months. </p><br>