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

NCT05485558 | Completed Phase 2

• 1 other identifier: NAC in DRE.
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Drug Resistant Epilepsy

Keywords

N-acetyl cysteine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• analyze the differences of improvement of quality of life via using Helth related quality of life questionnaire

  6 months

Study Arms (3)

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Drug: N-acetyl cysteine

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.

Drug: NAc

Interventions

N-acetyl cysteine DRUG

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

Also known as: NAC

N-acetyl cysteine group

Placebo DRUG

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

Also known as: control

Control group

NAc DRUG

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

N-actyl cysteine group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ahmed kishk, Lecturer

  Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 3, 2022
• Study Start: September 15, 2022
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)