Influence of cortisone therapy in childhood epilepsia on the immune systeme.

Influence of pulsatile dexamethasone therapy in childhood epilepsia on the immune Systeme.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002658-19-AT

Enrollment

Registered

2018-05-22

Start date

2018-06-25

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analization of specific immune cells and immune modulation factors in children under pulsatile dexamethasone-therapy.

Interventions

Pharmaceutical Form: Infusion INN or Proposed INN: DEXAMETHASONE CAS Number: 50-02-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4mg-

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Immunodeficiencies, genetic Syndroms with immunodeficiencies (e.g. Trisomia 21), Prior immunosuppressive therapy, major infections and illnesses

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Biomarkers;Timepoint(s) of evaluation of this end point: week 0,4, months 3, 6, 12	—

Primary

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactDepartment of Pediatrics I

Department of Pediatrics I, Medical University of Innsbruck

+4351250423501

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026