Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05485558
Other study ID # NAC in DRE.
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04378075 - A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy Phase 2/Phase 3
Recruiting NCT05928598 - Goals for Epilepsy Clinic Visits Trial N/A
Recruiting NCT05539287 - Clinical Study Evaluating the Safety of Lactobacillus Probiotic in Children With Drug Resistant Epilepsy Phase 2
Not yet recruiting NCT04601974 - Lentiviral Gene Therapy for Epilepsy Phase 1/Phase 2
Completed NCT02982824 - Effect of Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy N/A
Not yet recruiting NCT04553354 - Cortical Resections in Drug Resistant Epilepsy
Recruiting NCT04999046 - NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy N/A
Recruiting NCT04714996 - Efficacy, Safety and Pharmacokinetics of ES-481 in Adult Patients With Drug Resistant Epilepsy Phase 2
Recruiting NCT04839601 - RNS System RESPONSE Study N/A
Recruiting NCT06059157 - Epileptogenic Network Visualisation With Advanced MRI N/A
Recruiting NCT05947656 - Evaluation of the NaviFUS System in Drug Resistant Epilepsy N/A
Recruiting NCT05393518 - Electroclinical Correlation of Anxiety N/A
Not yet recruiting NCT05555537 - MiRNA223 and HMGB1 as Apredictos for Drug Resistant Epilepsy
Completed NCT03419000 - Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY N/A
Enrolling by invitation NCT06341075 - Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy N/A
Not yet recruiting NCT05527093 - Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy N/A
Recruiting NCT05697614 - The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children Phase 4
Recruiting NCT06309251 - Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients
Recruiting NCT06432907 - StereoEEG Motor Neuronal Potentials Decoding N/A
Not yet recruiting NCT06340802 - A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl N/A