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

Phase 2

Recruiting

• Conditions: Drug Resistant Epilepsy
• Interventions: Drug: N-acetyl cysteine; Drug: Placebo; Drug: NAc

• Registration Number: NCT05485558
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2022-07-30
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Study Start: 2022-09-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-20
• Last Update Posted: 2023-05-23
• Primary Completion: 2024-06-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetyl cysteine group	N-acetyl cysteine	15 patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
Control group	Placebo	15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.
N-actyl cysteine group	NAc	15 patients will receive 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt