Patients aged 2-18 years with a diagnosis of epilepsy, currently receiving Levetiracetam monotherapy. Nervous System Diseases
Conditions
Interventions
This study is designed as a prospective pre–post investigation in which each participant serves as their own control. Immunological indices—including IgG, IgA, IgM, IgG subclasses (IgG1–IgG4), anti-te
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Pediatric patients diagnosed with epilepsy 2. Age between 2 and 18 years 3. Patients who start levetiracetam as monotherapy 4. Informed consent obtained from parents or guardians
Exclusion criteria
Exclusion criteria: 1. Previous treatment with antiseizure drugs 2. Known immune disorders 3. Presence of acute infection during enrollment 4. Use of immunosuppressive medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum immunoglobulin G (IgG) concentration, as a marker of humoral immunity, measured using standard laboratory methods and validated assay kits to assess venous blood samples at study entry (before initiation of levetiracetam monotherapy) and 6 months after initiation of levetiracetam monotherapy;Serum immunoglobulin G subclasses, including IgG1, IgG2, IgG3, and IgG4, as markers of humoral immunity, measured using standard laboratory methods and validated assay kits to assess venous blood samples, at study entry (before initiation of levetiracetam monotherapy) and 6 months after initiation of levetiracetam monotherapy;Serum immunoglobulin A (IgA) concentration, as a marker of humoral immunity, measured using standard laboratory methods and validated assay kits to assess venous blood samples, at study entry (before initiation of levetiracetam monotherapy) and 6 months after initiation of levetiracetam monotherapy;Serum immunoglobulin M (IgM) concentration, as a marker of humoral immunity, measured using standard laboratory methods and validated assay kits to assess venous blood samples, at study entry (before initiation of levetiracetam monotherapy) and 6 months after initiation of levetiracetam monotherapy;Serum anti-tetanus antibody titer, as an indicator of specific immune response measured using standard laboratory methods and validated assay kits to assess venous blood samples, at study entry (before initiation of levetiracetam monotherapy) and 6 months after initiation of levetiracetam monotherapy;T-cell subsets, including CD4+ and CD8+, measured using standard laboratory methods and validated assay kits to assess venous blood samples, at study entry (before initiation of levetiracetam monotherapy) and 6 months after initiation of levetiracetam monotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of active infections (such as respiratory, gastrointestinal, or urinary tract infections) during the treatment period measured using data collected from parental reports, clinical examinations, and review of medical records, at the 6-month follow-up after initiation of levetiracetam monotherapy | — |
Countries
Iran
Contacts
Public ContactGolazin Shahbodagh Khan
Outcome results
None listed