Evaluating N-acetyl cysteine for treating drug-resistant epilepsy in children
Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
This study is testing if a supplement called N-acetyl cysteine can help children aged 3-18 with epilepsy that doesn't respond to regular medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT05485558 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of N-acetyl cysteine (NAC) as an additional treatment for children aged 3-18 years with drug-resistant epilepsy. NAC is a precursor to glutathione and may help reduce oxidative stress and neuroinflammation associated with epilepsy. The trial will compare the effects of NAC against a placebo to determine its potential benefits in managing this challenging condition. Participants must meet specific inclusion criteria and will be monitored for compliance and safety throughout the study.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-18 years diagnosed with intractable childhood-onset epilepsy.
Not a fit: Patients with metabolic conditions that increase trial risks or those allergic to N-acetyl cysteine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children suffering from drug-resistant epilepsy.
How similar studies have performed: While the use of N-acetyl cysteine in epilepsy is being explored, this specific approach is novel and has not been extensively tested in this population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tanta
- Tanta University — Tanta, Egypt (Recruiting)
Study contacts
- Study coordinator: Amira Rashdan, master
- Email: amira.rashdan@pharm.tanta.edu.eg
- Phone: 01022677143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.