the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy

Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05485558

Enrollment

Registered

2022-08-03

Start date

2022-09-15

Completion date

2025-01-01

Last updated

2025-07-01

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

Conditions

Drug Resistant Epilepsy

Keywords

N-acetyl cysteine

Brief summary

This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy

Detailed description

N-acetyl-cysteine (NAC), a glutathione precursor, is proven to activate the nuclear factor E2-related factor 2( Nrf2) in mouse models of status epilepticus, thus inhibiting high mobility group box 1 (HMGB1) cytoplasmic translocation in the hippocampal neural and glial cells and preventing the linkage between oxidative stress and neuroinflammation for which the redox-sensitive protein HMGB1 is central. Therefore,It may be useful as an adjuvant in treating various medical conditions, especially neuropsychiatry.

Interventions

DRUGN-acetyl cysteine

10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.

DRUGPlacebo

15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.

DRUGNAc

40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double blind

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Patients aged 3-18 years with intractable childhood-onset epilepsy. * All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition. * The subject is willing and able to comply with the study requirements

Exclusion criteria

* Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR \< 60 mL/min/1.73 m2 or electrolyte imbalance. * Patients with Known allergy to N-acetyl cysteine. * Patients taking antioxidant and/or anti-inflammatory medications

Design outcomes

Primary

Measure	Time frame	Description
effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.	6 months	effectivness can be defined as more than 50% reduction in number of seizures.

Secondary

Measure	Time frame	Description
analyze the differences of improvement of quality of life via using Helth related quality of life questionnaire	6 months	Caregivers will complete the Quality of Life in Childhood Epilepsy (QOLCE) Scale(QOLCE-55).The QOLCE-55 sections' included the following domains: cognitive, emotional, social, and physical functioning Each item is on a 6-point Likert scale and includes anchors that are subjectively rated based on perceived QOL (e.g., 1 = very often, 2 = fairly often, 3 = sometimes, 4 = almost never, 5 = never, 6 = non-applicable). Caregivers completed the Quality of Life in Childhood Epilepsy (QOLCE) Scale.17

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026