An interventional study of blood sample in Drug Resistant Epilepsy, sponsored by Hospices Civils de Lyon. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
Among 35 studies in Drug Resistant Epilepsy with a site in France — 16 open to participants now, 17 under way, 1 of them phase 3. Drug Resistant Epilepsy · France.
Among the 35 studies in Drug Resistant Epilepsy with a site in France, this one is the 13th largest by enrollment of the 24 interventional ones, is one of 6 that started in 2018, is one of 12 with no phase, and was the 10th registered.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's enrollment of 75 is above the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →16 of the 35 studies in Drug Resistant Epilepsy with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 66 Drug Resistant Epilepsy studies recruiting now, 26 (39%) set no upper age limit and 39 (59%) stop at 75 or younger; 25 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →35 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 6 started in 2018.
Median enrollment 82 across the 24 interventional studies, 110 across the 11 observational. Of the 14 that completed or were terminated, 5 (36%) have results posted.
11 of 35 have an industry lead sponsor. The 10 most frequent:
Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Hospices Civils de Lyon has 5 studies filed under Drug Resistant Epilepsy — fewer than ten, so there is no comparison to draw.
5 of the studies in Drug Resistant Epilepsy with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06132893Phase 3Biohaven Therapeutics Ltd.A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | 2026-12 |
| NCT06443463Biohaven Therapeutics Ltd.Long-term Safety and Tolerability of BHV-7000 | 2026-12 |
| NCT06334952Assistance Publique Hopitaux De MarseilleEfficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic | 2026-12-18 |
| NCT06138808Duke University5-SENSE Score Validation Study | 2027-01 |
| NCT07898397University Hospital, Strasbourg, FranceLong-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke | 2027-02-28 |
Among the 35 studies in Drug Resistant Epilepsy with a site in France, from their registry updates:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the patients :
For the healthy volunteers :
Exclusion Criteria:
For the patients :
For the healthy volunteers :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Genetic: blood sample
Adult (≥ 18 years) Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders
Genetic: blood sample
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
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%
Time frame: Day 0
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
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
Ran from Mar 2018 to primary completion in Mar 2022, 48 months.
Of 90 non-industry interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21. This study's 48 months is above that.
Counting every sponsor, half of 102 studies reached it within 34 months; a quarter within 21 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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