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

NCT ID: NCT05485558

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2025-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

N-acetyl cysteine group

30patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.

Group Type: ACTIVE_COMPARATOR

N-acetyl cysteine

Intervention Type: DRUG

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

N-actyl cysteine group

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

Group Type: ACTIVE_COMPARATOR

NAc

Intervention Type: DRUG

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

Interventions

N-acetyl cysteine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

NAc

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

Intervention Type: DRUG

Other Intervention Names

NAC; control

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Amira Roshdy

Assistant Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed kishk, Lecturer

Role: STUDY_DIRECTOR

Tanta University

Locations

Tanta University

Tanta, , Egypt

Countries

Egypt

Other Identifiers

NAC in DRE.

Identifier Type: -

Identifier Source: org_study_id