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

Primary Purpose

Drug Resistant Epilepsy

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

N-acetyl cysteine

Placebo

NAc

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring N-acetyl cysteine

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

N-acetyl cysteine group

N-actyl cysteine group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05485558

First Posted

July 30, 2022

Last Updated

May 20, 2023

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT05485558

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Resistant Epilepsy

Keywords

N-acetyl cysteine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

N-acetyl cysteine group

Arm Type

Active Comparator

Arm Description

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

Arm Title

N-actyl cysteine group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

N-acetyl cysteine

Other Intervention Name(s)

NAC

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

control

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NAc

Intervention Description

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

Primary Outcome Measure Information:

Title

effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.

Description

effectivness can be defined as more than 50% reduction in number of seizures.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amira Rashdan, master

Phone

01022677143

amira.rashdan@pharm.tanta.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

tarek mostafa, professor

Phone

01154594035

tarek.mostafa@pharm.tanta.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed kishk, Lecturer

Organizational Affiliation

Tanta University

Official's Role

Study Director

Facility Information:

Facility Name

Tanta University

City

Tanta

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

amira roshdy, assisstant lecturer

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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