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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | 30 patients will receive standard antiepileptic drug plus placebo capsules for 6 months. |
|
| N-acetyl cysteine group | Active Comparator | 30patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. |
|
| N-actyl cysteine group | Active Comparator | 30 patients will receive 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl cysteine | Drug | 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Patients aged 3-18 years with intractable childhood-onset epilepsy.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed kishk, Lecturer | Tanta University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Egypt |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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double blind
| Placebo | Drug | 15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months. |
|
|
| NAc | Drug | 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. |
|
| 6 months |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |