Effect of levetiracetam monotherapy on the immune profile in children with epilepsy

ISRCTN	ISRCTN16753384
DOI	https://doi.org/10.1186/ISRCTN16753384
Sponsor	Tehran University of Medical Sciences
Funder	Tehran University of Medical Sciences and Health Services

Submission date: 11/06/2026
Registration date: 19/06/2026
Last edited: 19/06/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Epilepsy is a common neurological condition in children that causes repeated seizures. Levetiracetam is one of the most frequently prescribed medicines to control these seizures and is often used on its own (monotherapy). While it is known to be effective at stopping seizures, researchers want to understand if taking this medicine over a long period affects a child’s immune system (the body’s natural defense system). This study aims to evaluate whether 6 months of levetiracetam treatment causes any changes to the immunological profile (the balance of immune cells and proteins) in children with epilepsy.

Who can participate?
Children newly diagnosed with epilepsy who were scheduled to start treatment with levetiracetam monotherapy at the study center.

What does the study involve?
Participants had their immune profile assessed at two specific time points: first, at the very beginning before starting the medication, and second, after they had been taking levetiracetam consistently for 6 months. This involved collecting clinical data and blood samples to measure and compare immune markers at the start and end of the 6 months.

What are the possible benefits and risks of participating?
There was no direct clinical benefit to the participants. However, the results of this study will help doctors and scientists better understand how levetiracetam affects the developing immune system in children, which may help improve treatment safety. The risks were minimal and limited to the minor discomfort, brief pain, or bruising typically associated with providing a blood sample.

Where is the study run from?
The study was conducted at the Children’s Medical Center, which is a tertiary children’s referral center affiliated with the Tehran University of Medical Sciences (Iran).

When is the study starting and how long is it expected to run for?
January 2023 to September 2024.

Who is funding the study?
Tehran University of Medical Sciences (Iran).

Who is the main contact?
Golazin Shahbodagh Khan, Assistant Professor of Pediatric Neurology, Drshahbodagh@gmail.com

Contact information

Dr Golazin Shahbodagh Khan
Public, Scientific, Principal investigator

Children’s Medical Center, North Karegar Street
Tehran
1416753955
Iran

ORCID ID	0000-0002-3206-5728
Phone	+98-09122990864
Email	drshahbodagh@gmail.com

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Active
Assignment	Single
Purpose	Treatment
Scientific title	Impact of levetiracetam monotherapy on immunological profile in pediatric epilepsy: a prospective study
Study objectives
Ethics approval(s)	1. Approved 11/04/2023, The Ethics Committee of Tehran University of Medical Sciences (Tehran University of Medical Sciences (Central Administration), Enqelab-e Eslami Ave., at the intersection with Qods St., Tehran, 1416753955, Iran; +98 21 6147 9999; vcr@tums.ac.ir), ref: IR.TUMS.MEDICINE.REC.1402.028 2. Approved 05/06/2024, Research Ethics Committees of Children's Medical Center - Tehran University of Medical Sciences (Children’s Medical Center Ethics Committee, Dr Gharib Street, Keshavarz Boulevard, Tehran, 1419733151, Iran; -; chmc_research@tums.ac.ir), ref: IR.TUMS.CMHC.REC.1403.070
Health condition(s) or problem(s) studied	Patients aged 2-18 years with a diagnosis of epilepsy, currently receiving Levetiracetam monotherapy.
Intervention	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-tetanus antibody titers, flow cytometry and WBCs will be assessed at two time points: prior to initiation of levetiracetam monotherapy and 6 months after treatment. To minimize confounding, children with acute infection at enrollment, known immune disorders, or current use of immunosuppressive medications will be excluded. All laboratory analyses will be performed at the Children’s Medical Center laboratory.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Levetiracetam
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	05/09/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	2 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	52
Total final enrolment	30
Key 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
Key exclusion criteria	1. Previous treatment with antiseizure drugs 2. Known immune disorders 3. Presence of acute infection during enrollment 4. Use of immunosuppressive medications
Date of first enrolment	15/04/2023
Date of final enrolment	01/04/2024

Locations

Countries of recruitment

Iran

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	De-identified participant data including the primary and secondary study variables will be available after publication of the study results upon reasonable research request and with approval of the principal investigator, Dr Golazin Shahbodagh Khan, drshahbodagh@gmail.com.

Editorial Notes

19/06/2026: Study’s existence confirmed by the Ethics Committee of Tehran University of Medical Sciences, Iran.