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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Drug Resistant Epilepsy

Intervention / Treatment
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* Drug: N-acetyl cysteine
* Drug: Placebo
* Drug: NAc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-acetyl cysteine