Influence of cortisone therapy in childhood epilepsia on the immune systeme.
Phase 1
- Conditions
- Analization of specific immune cells and immune modulation factors in children under pulsatile dexamethasone-therapy.Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-002658-19-AT
- Lead Sponsor
- Department für Kinder- und Jugendheilkunde, Pädiatrie I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
children with West-Syndrome, Lennox-Gastaut-Syndrome, Continuous Spike-Waves during Slow Sleep (CSWS Syndrom) / Electrical Status epilepticus in slow Sleep (ESES); healthy age matched controls
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
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
Exclusion Criteria
Immunodeficiencies, genetic Syndroms with immunodeficiencies (e.g. Trisomia 21), Prior immunosuppressive therapy, major infections and illnesses
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the influence of pulsatile dexamethasone therapy on the immuny system in children with epilepsia.;Secondary Objective: Not applicable;Primary end point(s): End of the Treatment Intervall (5 applications of i.v. dexamethasone with a break of 4 weeks in between);Timepoint(s) of evaluation of this end point: week 0,4, months 3, 6, 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Biomarkers;Timepoint(s) of evaluation of this end point: week 0,4, months 3, 6, 12