Drug Resistant EpilepsyPhase 2NCT05485558
the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
A Phase 2 study testing N-acetyl cysteine and NAc in people with Drug Resistant Epilepsy, run by Tanta University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- N-acetyl cysteine and NAc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to 1 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy
Read the 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.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- N-acetyl cysteine, Placebo, NAc
- Keywords
- N-acetyl cysteine
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called NAC
10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
PlaceboDrug
Also called control
15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.
NAcDrug
40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 30 patients will receive standard antiepileptic drug plus placebo capsules for 6 months. Receives: Drug: Placebo |
| N-acetyl cysteine group | Active comparator | 30patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. Receives: Drug: N-acetyl cysteine |
| N-actyl cysteine group | Active comparator | 30 patients will receive 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. Receives: Drug: NAc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start15 Sep 2022
- Primary completion1 Jun 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Roshdy, Tanta University
- Investigators
- Ahmed kishk, Lecturer, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485558
- Sponsor's protocol ID
- NAC in DRE.
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT05485558
- Acronym / sponsor ID
- NAC in DRE.
- Conditions
- Drug Resistant Epilepsy
- Keywords
- N-acetyl cysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placebo30 patients will receive standard antiepileptic drug plus placebo capsules for 6 months. |
| N-acetyl cysteine group | Active comparator | Drug: N-acetyl cysteine30patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. |
| N-actyl cysteine group | Active comparator | Drug: NAc30 patients will receive 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 3-18 years with intractable childhood-onset epilepsy.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineAlso: NAC10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. | Drug | N-acetyl cysteine group |
| PlaceboAlso: control15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months. | Drug | Control group |
| NAc40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months. | Drug | N-actyl cysteine group |
Primary outcome
effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.
Time frame: 6 months
effectivness can be defined as more than 50% reduction in number of seizures.
1 secondary outcome
analyze the differences of improvement of quality of life via using Helth related quality of life questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed kishk, Lecturer study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetyl cysteine and NAc in people with Drug Resistant Epilepsy, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.