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

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

Study Overview

• Status: Completed
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Drug: N-acetyl cysteine; Drug: Placebo; Drug: NAc

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 30 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.	Drug: Placebo; 15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.; Other Names: control
Active Comparator: N-acetyl cysteine group; 30patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.	Drug: N-acetyl cysteine; 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.; Other Names: NAC
Active Comparator: N-actyl cysteine group; 30 patients will receive 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.	Drug: NAc; 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Ahmed kishk, Lecturer, Tanta university

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: N-acetyl cysteine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Antioxidants; Protective Agents; Expectorants; Respiratory System Agents; Free Radical Scavengers; Antidotes; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: NAC in DRE.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No