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

Tanta University90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Drug Resistant Epilepsy

Interventions

N-acetyl cysteineDRUG

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

PlaceboDRUG

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

NAcDRUG

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

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tanta University

Tanta, Egypt

Outcomes

Primary Outcomes

effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.

effectivness can be defined as more than 50% reduction in number of seizures.

Time frame: 6 months

Secondary Outcomes

analyze the differences of improvement of quality of life via using Helth related quality of life questionnaire

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

Time frame: 6 months

Data from ClinicalTrials.gov

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