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Clinical trial

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

ID
Name
NAC in DRE.
Description
This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy
Trial arms
Trial start
2022-09-15
Estimated PCD
2024-06-01
Trial end
2026-05-01
Status
Recruiting
Phase
Early phase I
Treatment
N-acetyl cysteine
10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
Arms:
N-acetyl cysteine group
Other names:
NAC
Placebo
15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.
Arms:
Control group
Other names:
control
NAc
40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
Arms:
N-actyl cysteine group
Size
45
Primary endpoint
effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.
6 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2023-05-23

1 organization

2 products

1 drug

1 indication

Organization
Tanta University
Product
N-acetyl cysteine
Indication
Drug-Resistant Epilepsy
Drug
Varlilumab
Product
NAc