Drug Resistant EpilepsyMIRESPILEPSYNCT03419000
Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY
A study testing blood sample in people with Drug Resistant Epilepsy, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus, in which postmortem examination does not reveal a toxicologic or anatomic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Mar 2018to 31 Mar 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the patients :
- Adult patient (≥ 18 years) suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification
- Patient undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure
- Patient who gave her/his written informed consent to participate to the study
- Patient affiliated to the French health care system
- For the healthy volunteers :
Show all 10Show fewer
- Adult (≥ 18 years)
- Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders
- Subject who gave her/his written informed consent to participate to the study
- Subject affiliated to the French health care system
Who cannot join
- For the patients :
- Ongoing major depressive episode as defined by a score ≥ 15 at the French version of the NDDI-E scale*
- Current panic disorder as defined by a score ≥ 7 at the French version of the GAD-7 scale*
- Ongoing treatment with selective serotonin reuptake inhibitor
- Patient who benefit from a protective measure
- For the healthy volunteers :
Show all 9Show fewer
- Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)
- Ongoing treatment with selective serotonin reuptake inhibitor
- Subjects with these psychiatric comorbidities and/or treatment will be excluded in order to limit risk that the relation previously reported between miR-135a, miR-16, miR-1202 and depression and/or panic disorder and/or response to selective serotonin
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon
Bron, 69500
Service de Neurophysiologie Clinique Hôpital La Timone
Marseille, 13005
About this study
Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus, in which postmortem examination does not reveal a toxicologic or anatomic cause of death. It primarily affects young adults with drug-resistant epilepsy, with an incidence of about 0.5%/year. A recent study reported that up to 20% of patients with childhood onset drug resistant epilepsy will die of a SUDEP by the age of 45. Apart from optimizing antiepileptic drugs, no preventive treatment is available to prevent SUDEP. As underscored by the World Health Organization (WHO), there is an urgent need to develop specific therapeutic approaches to tackle this issue.
The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%.
Read more
A total of 50 patients will be included over a period of one year. Patients undergoing long-term video-EEG/SEEG monitoring will be recruited in the epilepsy monitoring unit of the Department of Functional Neurology and Epileptology, Hospices Civils de Lyon, Lyon, France.
It will be a case-control study in a cohort of patients with drug-resistant focal epilepsy undergoing long-term video-EEG monitoring, in which patients who demonstrate ictal/post-ictal hypoxemia (cases) will be compared with those without seizure-related respiratory dysfunction (controls).
- Conditions
- Drug Resistant Epilepsy
- Being tested
- blood sample
- Keywords
- GTCS, Epilepsies, Partial, Drug Resistant Epilepsy, Circulating MicroRNA, Diagnostic
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsies, Partial, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleGenetic
Seven blood samples (4 ml each on 5 EDTA and 2 dry tubes) will be collected in each patient/ healthy volunteers subject to determine the expression profile of miRNAs in the plasma as well as in the exosomes
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Patients suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification and undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure Receives: Genetic: blood sample |
| healthy volunteers | Active comparator | Adult (≥ 18 years) Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders Receives: Genetic: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between the expression level of circulating microRNAs and the occurrence of SpO2 <90% during at least 5 seconds within the course of the seizure and/or within the five minutes following the end of the seizure
The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%
Measured: Day 0
Secondary outcomes (5)
Relation between the expression level of circulating microRNAs and the desaturation nadir
Evaluating the relation between a set of circulating microRNAs and the severity of the seizure-related respiratory dysfunction, as defined by the desaturation nadir
Measured: Day 0
Relation between the expression level of circulating microRNAs and the patient's age
Measured: Day 0
Relation between the expression level of circulating microRNAs and the epilepsy duration
Measured: Day 0
Relation between the expression level of circulating microRNAs and the total number of seizures (ie focal seizures and GTCS) over the past three months
Measured: Day 0
Relation between the expression level of circulating microRNAs and the Number of GTCS over the past three months
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start16 Mar 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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 Hospices Civils de LyonThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain RHEIMS, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419000
- Sponsor's protocol ID
- 69HCL17_0666
- Other IDs
- 2017-A03307-46
- Acronym
- MIRESPILEPSY
- Status last verified
- Apr 2022
- First submitted
- 26 Jan 2018
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY
- ClinicalTrials.gov ID
- NCT03419000
- Acronym / sponsor ID
- MIRESPILEPSY / 69HCL17_0666
- Conditions
- Drug Resistant Epilepsy
- Keywords
- GTCS, Epilepsies, Partial, Drug Resistant Epilepsy, Circulating MicroRNA, Diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 1 Feb 2018 (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.
Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus, in which postmortem examination does not reveal a toxicologic or anatomic cause of death. It primarily affects young adults with drug-resistant epilepsy, with an incidence of about 0.5%/year. A recent study reported that up to 20% of patients with childhood onset drug resistant epilepsy will die of a SUDEP by the age of 45. Apart from optimizing antiepileptic drugs, no preventive treatment is available to prevent SUDEP. As underscored by the World Health Organization (WHO), there is an urgent need to develop specific therapeutic approaches to tackle this issue.
The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%.
A total of 50 patients will be included over a period of one year. Patients undergoing long-term video-EEG/SEEG monitoring will be recruited in the epilepsy monitoring unit of the Department of Functional Neurology and Epileptology, Hospices Civils de Lyon, Lyon, France.
It will be a case-control study in a cohort of patients with drug-resistant focal epilepsy undergoing long-term video-EEG monitoring, in which patients who demonstrate ictal/post-ictal hypoxemia (cases) will be compared with those without seizure-related respiratory dysfunction (controls).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Genetic: blood samplePatients suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification and undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure |
| healthy volunteers | Active comparator | Genetic: blood sampleAdult (≥ 18 years) Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patient (≥ 18 years) suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification
- Patient undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure
- Patient who gave her/his written informed consent to participate to the study
- Patient affiliated to the French health care system
- Adult (≥ 18 years)
Key exclusion criteria (9 listed)
- Ongoing major depressive episode as defined by a score ≥ 15 at the French version of the NDDI-E scale*
- Current panic disorder as defined by a score ≥ 7 at the French version of the GAD-7 scale*
- Ongoing treatment with selective serotonin reuptake inhibitor
- Patient who benefit from a protective measure
- Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS)
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 |
|---|---|---|
| blood sampleSeven blood samples (4 ml each on 5 EDTA and 2 dry tubes) will be collected in each patient/ healthy volunteers subject to determine the expression profile of miRNAs in the plasma as well as in the exosomes | Genetic | Patient, healthy volunteers |
Primary outcome
Relation between the expression level of circulating microRNAs and the occurrence of SpO2 <90% during at least 5 seconds within the course of the seizure and/or within the five minutes following the end of the seizure
Time frame: Day 0
The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%
5 secondary outcomes
Relation between the expression level of circulating microRNAs and the desaturation nadir
Time frame: Day 0
Relation between the expression level of circulating microRNAs and the patient's age
Time frame: Day 0
Relation between the expression level of circulating microRNAs and the epilepsy duration
Time frame: Day 0
Relation between the expression level of circulating microRNAs and the total number of seizures (ie focal seizures and GTCS) over the past three months
Time frame: Day 0
Relation between the expression level of circulating microRNAs and the Number of GTCS over the past three months
Time frame: Day 0
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 24 Sep 2025.
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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.
Sylvain RHEIMS principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Drug Resistant Epilepsy, run by Hospices Civils de Lyon at 2 sites in France.
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 10 inclusion and 9 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. 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?
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?
Relation between the expression level of circulating microRNAs and the occurrence of SpO2 <90% during at least 5 seconds within the course of the seizure and/or within the five minutes following the end of the seizure (time frame: Day 0). 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 24 Sep 2025.