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Completed

NCT Number: NCT05485558

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

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Key information

Conditions

Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta University

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetyl cysteine

Drug

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

Other names: NAC

Placebo

Drug

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

Other names: control

NAC

Drug

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

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 3, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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