Clinical trial · Interventional
Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex
NCT02098759CI-TRIAL-00014181EPISTOPunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epilepsy | — | UNRESOLVED | — |
| TSC | — | UNRESOLVED | — |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epilepsy early diagnosis protocol | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- epilepsy early diagnosis
- description
- 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, 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.
- interventionNames
- Device: epilepsy early diagnosis protocol
- type
- EXPERIMENTAL
- label
- standard epilepsy diagnosis
- description
- 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, 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 4 Months
Show eligibility criteria text
Inclusion criteria Inclusion criteria for TSC patients: * 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. Inclusion criteria for the control group: * male or female infants who have undergone routine MRI for reasons other than epilepsy and brain tumor or cortical defects, * age up to 24 months at the moment of study entry, * written informed consent of caregivers. Exclusion criteria Exclusion criteria for TSC patients: * 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. Exclusion criteria for the control group: * any sign or symptom suggesting TSC diagnosis, * any type of seizures observed at study entry, * antiepileptic treatment at study entry, * history of seizures, with the exception of febrile seizures, * any severe and/or uncontrolled medical condition that is considered by the investigator as possibly affecting the EPISTOP analyses or procedures.
References
Publications (1)
- DERIVEDvan der Poest Clement E, Jansen FE, Braun KPJ, Peters JM. Update on Drug Management of Refractory Epilepsy in Tuberous Sclerosis Complex. Paediatr Drugs. 2020 Feb;22(1):73-84. doi: 10.1007/s40272-019-00376-0. PMID 31912454