ong-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex
- Conditions
- epilepsy in tuberous sclerosis complex (TSC)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-005528-40-BE
- Lead Sponsor
- Vrije Universiteit Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
-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 randomized part of the study
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method