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

Drug Resistant Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485558
• Other study ID #: NAC in DRE.
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2022
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2023
• Source: Tanta University
• Contact: Amira Rashdan, master
• Phone: 01022677143
• Email: amira.rashdan[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 1, 2026
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Drug:
• N-acetyl cysteine
10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
• Placebo
15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.
• NAc
40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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