Drug Resistant EpilepsyNCT05555537
MiRNA223 and HMGB1 as Apredictos for Drug Resistant Epilepsy
An observational study of Drug Resistant Epilepsy, run by Assiut University.
Trial summary
Evaluation of the role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy. Early detection of the prognosis might help in guiding patients for proper management and treatment strategy. This may open the door for new drug trials. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- MiRNA223 and High mobility group box1(HMGB1)
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 Nov 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Drug resistant epilepsy defined as(failure to achieve sustained seizure freedom after adequate and well tolerated trials of two anti-seizure medications) Well controlled epilepsy defined as(seizure freedom for at least the last 6months) matched in sex and age.
Who may be able to join
- Patients diagnosed as drug resistant epilepsy .
- Control group: patients diagnosed as medically controlled epilepsy
Who cannot join
- Symptomatic epilepsy (vascular, tumor, post encephalitic, syndromic and febrile seizures).
- Alzheimers disease
- Parkinsons disease
- amyotrophic lateral sclerosis
- major depression disorder
- Non neurological criteria: tumors and cardiovascular
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Plasma miRNA223 and High Mobility Group Box 1(HMGB1) as Predictors of Drug Resistant Epilepsy
Evaluation of the role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy.
Early detection of the prognosis might help in guiding patients for proper management and treatment strategy.
This may open the door for new drug trials.
Read the detailed description
Epilepsy is the most prevalent neurological disorders (1). Drug-resistant epilepsy (DRE) represent approximately 30% of epilepsy..DRE is defined as failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications( ASMs).The identification of circulating biomarkers for DRE could give an early idea about the prognosis and improve the choice of correct treatment.
MiRNAs are small noncoding RNAs that span between 19 and 24 nucleotide bases((2).They gain biological activity through base pairing in the 30-untranslated regions of target messenger RNA (mRNA) , thereby guiding a protein complex termed the RNA-induced silencing complex (RISC) that bind to the mRNA sequence and results in either the inhibition of translational processes or the degradation of the mRNA (3). Dysregulated miRNA expression has been associated with inflammatory pathways, cell death, neuronal excitability, and synaptic reorganization, which underlie epileptogenesis (4).
High- mobility group box 1(HMGB1) is a chromatin component that is physiologically attached to nuclei. However, following CNS insult, it can promptly be migrated towards cytoplasm and is discharged extracellularly. HMGB1mediates sterile neuro-inflammation evoked by epileptogenic injury and recurrent seizures(5) .HMGB1 increases in neurons, glia, and endothelial cells of the blood brain barrier (BBB) in DRE.
The HMGB1 contributes to the overexpression of P-glycoprotein, a BBB protein, which is induced in DRE foci and extrudes various ASMs from the brain(6) .
- Conditions
- Drug Resistant Epilepsy
- Being tested
- MiRNA223 and High mobility group box1(HMGB1)
- 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.
MiRNA223 and High mobility group box1(HMGB1)Diagnostic test
Measure tye 2 biomarkers miRNA223 and HMGB1 in drug resistant and in medically controled epilepsy
| Study group | Role | What they receive |
|---|---|---|
| Drug resistant epilepsy | failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications Receives: Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1) | |
| Medically controled epilepsy | seizure freedom for at least the last 6months) matched in sex and age. Receives: Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy.
Early detection of being drug resistant epilepsy might help in guiding patients for proper management and treatment strategy.
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
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 Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Ali Samir Hussien Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555537
- Sponsor's protocol ID
- drug resistant epilepsy
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Plasma miRNA223 and High Mobility Group Box 1(HMGB1) as Predictors of Drug Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT05555537
- Acronym / sponsor ID
- drug resistant epilepsy
- Conditions
- Drug Resistant Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 27 Sep 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.
Evaluation of the role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy.
Early detection of the prognosis might help in guiding patients for proper management and treatment strategy.
This may open the door for new drug trials.
Detailed description
Epilepsy is the most prevalent neurological disorders (1). Drug-resistant epilepsy (DRE) represent approximately 30% of epilepsy..DRE is defined as failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications( ASMs).The identification of circulating biomarkers for DRE could give an early idea about the prognosis and improve the choice of correct treatment.
MiRNAs are small noncoding RNAs that span between 19 and 24 nucleotide bases((2).They gain biological activity through base pairing in the 30-untranslated regions of target messenger RNA (mRNA) , thereby guiding a protein complex termed the RNA-induced silencing complex (RISC) that bind to the mRNA sequence and results in either the inhibition of translational processes or the degradation of the mRNA (3). Dysregulated miRNA expression has been associated with inflammatory pathways, cell death, neuronal excitability, and synaptic reorganization, which underlie epileptogenesis (4).
High- mobility group box 1(HMGB1) is a chromatin component that is physiologically attached to nuclei. However, following CNS insult, it can promptly be migrated towards cytoplasm and is discharged extracellularly. HMGB1mediates sterile neuro-inflammation evoked by epileptogenic injury and recurrent seizures(5) .HMGB1 increases in neurons, glia, and endothelial cells of the blood brain barrier (BBB) in DRE.
The HMGB1 contributes to the overexpression of P-glycoprotein, a BBB protein, which is induced in DRE foci and extrudes various ASMs from the brain(6) .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug resistant epilepsy | – | Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1)failure to achieve sustained seizure freedom after adequate and well tolerated trials of two antiseizure medications |
| Medically controled epilepsy | – | Diagnostic Test: MiRNA223 and High mobility group box1(HMGB1)seizure freedom for at least the last 6months) matched in sex and age. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Drug resistant epilepsy defined as(failure to achieve sustained seizure freedom after adequate and well tolerated trials of two anti-seizure medications) Well controlled epilepsy defined as(seizure freedom for at least the last 6months) matched in sex and age.
Key inclusion criteria (2 listed)
- Patients diagnosed as drug resistant epilepsy .
- Control group: patients diagnosed as medically controlled epilepsy
Key exclusion criteria (6 listed)
- Symptomatic epilepsy (vascular, tumor, post encephalitic, syndromic and febrile seizures).
- Alzheimers disease
- Parkinsons disease
- amyotrophic lateral sclerosis
- major depression disorder
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 |
|---|---|---|
| MiRNA223 and High mobility group box1(HMGB1)Measure tye 2 biomarkers miRNA223 and HMGB1 in drug resistant and in medically controled epilepsy | Diagnostic test | Drug resistant epilepsy, Medically controled epilepsy |
Primary outcome
role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy.
Time frame: 2year
Early detection of being drug resistant epilepsy might help in guiding patients for proper management and treatment strategy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Resistant Epilepsy, run by Assiut University.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safaa Ali Ali, Assistant lecture (01018612254, safaa.samir191@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of estimation of serum level of miRNAs223 and HMGB1in detection of patient with drug resistant epilepsy. (time frame: 2year). 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 18 Oct 2022.