NCT05485558

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Resistant Epilepsy

Interventions

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

Timeline

• Start date: 2022-09-15
• Primary completion: 2024-06-01
• Completion: 2025-01-01
• First posted: 2022-08-03
• Last updated: 2025-07-01

Locations

1 site across 1 country: Egypt