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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Drug Resistant Epilepsy

Treatments: Drug: NAc; Drug: Placebo; Drug: N-acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05485558

NAC in DRE.

Details and patient eligibility

About

This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

N-acetyl cysteine group

Active Comparator group

Description:

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

Treatment:

Drug: N-acetyl cysteine

N-actyl cysteine group

Active Comparator group

Description:

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

Treatment:

Drug: NAc