Drug-resistant Partial EpilepsyREPOMSENCT02572297
National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
An observational study of Drug-resistant Partial Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient associations involved in epilepsy. These represent a priority for the Ligue Française Contre l'Epilepsie (LFCE). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Drug-resistant Partial Epilepsy
- What is being tested?
- video-EEG
- How many people
- 1,072 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2010to 23 Aug 2015
- How long will I take part?
- 10 Years
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from drud-resistant partial epilepsy whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment
Who may be able to join
- patients suffering from drud-resistant partial epilepsy ;
- Patients who are at least 15 years ;
- Patients for whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment ;
- Patients having a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number
- Patients who have given their written consent ;
- Patients with a social security
Who cannot join
- Patients under 15 years
- Patients without drug-resistant partial epilepsy
- Patients without a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number)
- Patient without a consent signed
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Pierre Wertheimer, Hospices Civils de Lyon
Bron, 69677
About this study
Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient associations involved in epilepsy. These represent a priority for the Ligue Française Contre l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years, suffering from epilepsy uncontrolled by medication. In this population of close to 100,000 people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per year. It is clear that the majority of these deaths occur in the immediate consequences of a crisis..
Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per / post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution of a cohort of 1500 patients clinically well described and a national database will allow other ambitious projects in a speciality where French centres benefit from a unique knowledge, recognized by their foreign colleagues, but underexploited to date. The LFCE (Ligue Française Contre l'Epilepsie) is developing structuring actions to facilitate such exploratory studies for the next two years.
Read more
The high death rate which characterizes the drug-resistant partial epilepsies and, in particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of research for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of epileptic patients and the European representatives of the international league against epilepsy ( ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned against SUDEP.
Although the SUDEP physiopathology remains uncertain, many elements plead for the essential role of a per-and post-critic apnea (central or obstructive). Investigators observe that about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their crisis are going to present experience an per / post-critic severe apnea, severe per / post-critic enough to have induce a SpO2 < 80 % decrease.
However, today, no study has estimated the link relation between the arisen occurrence of such apneas and the later risk of SUDEP.
- Conditions
- Drug-resistant Partial Epilepsy
- Being tested
- video-EEG
- Keywords
- epilepsy, SUDEP, SpO2
- Medical subject headings
- Epilepsy, Sudden Unexpected Death in Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-EEGOther
Registration of seizures during video-EEG
| Study group | Role | What they receive |
|---|---|---|
| video-EEG | Patients suffering from drug-resistant partial epilepsy for whom a video-EEG monitoring of their seizures was scheduled as part of pre-surgical assessment Receives: Other: video-EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with SpO2 < 80% decreases during the EEG-video monitoring
To establish a relation between the occurence of SpO2 < 80% decreases during a EEG-video monitoring and the later risk of SUDEP.
Measured: 6 and a half months
Secondary outcomes (2)
Frequence of other known potential risk factors (composite measure : presence rate of each risk factor in SUDEP measured as percentage)
To test the other potential risk factors of known or still under exploration SUDEPs or still in study (area of the beginning of epilepsy, the abnormalities of sinusal variability). Known potential risk factors are : etiology; epilepsy starting age and duration; crisis frequency in the last 12 months; crisis frequency of secondarly generalized crisis in the last 12 months; presence of nocturnal crisis in the last 12 months; number of concomitant traitments; carbamapezin treatment, Body Mass Indice, sleep apnea syndrome, mood disorder, life qualitity, treatment side effects.
Measured: 6 and a half months
Allelic frequency of genes involved in epileptogenesis (measured as percentage)
Evaluation of the genetic polymorphism of the monoaminergic system or of genes involved in the early epilepsy stage mechanisms of early stages of epilepsy.
Measured: 6 and a half months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start18 May 2010
- Primary completionFeb 2015
- Study completion23 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-resistant Partial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,072 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe RYVLIN, MD, Principal investigator, Sercie de neurologie fonctionnelle et d'epileptologie, Hôpital Neurologique Pierre Wertheimer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572297
- Sponsor's protocol ID
- 2009.582
- Acronym
- REPOMSE
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2015
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
- ClinicalTrials.gov ID
- NCT02572297
- Acronym / sponsor ID
- REPOMSE / 2009.582
- Conditions
- Drug-resistant Partial Epilepsy
- Keywords
- epilepsy, SUDEP, SpO2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,072 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 May 2010 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- 23 Aug 2015 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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 unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient associations involved in epilepsy. These represent a priority for the Ligue Française Contre l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years, suffering from epilepsy uncontrolled by medication. In this population of close to 100,000 people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per year. It is clear that the majority of these deaths occur in the immediate consequences of a crisis..
Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per / post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution of a cohort of 1500 patients clinically well described and a national database will allow other ambitious projects in a speciality where French centres benefit from a unique knowledge, recognized by their foreign colleagues, but underexploited to date. The LFCE (Ligue Française Contre l'Epilepsie) is developing structuring actions to facilitate such exploratory studies for the next two years.
The high death rate which characterizes the drug-resistant partial epilepsies and, in particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of research for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of epileptic patients and the European representatives of the international league against epilepsy ( ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned against SUDEP.
Although the SUDEP physiopathology remains uncertain, many elements plead for the essential role of a per-and post-critic apnea (central or obstructive). Investigators observe that about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their crisis are going to present experience an per / post-critic severe apnea, severe per / post-critic enough to have induce a SpO2 < 80 % decrease.
However, today, no study has estimated the link relation between the arisen occurrence of such apneas and the later risk of SUDEP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video-EEG | – | Other: video-EEGPatients suffering from drug-resistant partial epilepsy for whom a video-EEG monitoring of their seizures was scheduled as part of pre-surgical assessment |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from drud-resistant partial epilepsy whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment
Key inclusion criteria (6 listed)
- patients suffering from drud-resistant partial epilepsy ;
- Patients who are at least 15 years ;
- Patients for whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment ;
- Patients having a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number
- Patients who have given their written consent ;
Key exclusion criteria (4 listed)
- Patients under 15 years
- Patients without drug-resistant partial epilepsy
- Patients without a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number)
- Patient without a consent signed
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 |
|---|---|---|
| video-EEGRegistration of seizures during video-EEG | Other | video-EEG |
Primary outcome
Number of patients with SpO2 < 80% decreases during the EEG-video monitoring
Time frame: 6 and a half months
To establish a relation between the occurence of SpO2 < 80% decreases during a EEG-video monitoring and the later risk of SUDEP.
2 secondary outcomes
Frequence of other known potential risk factors (composite measure : presence rate of each risk factor in SUDEP measured as percentage)
Time frame: 6 and a half months
Allelic frequency of genes involved in epileptogenesis (measured as percentage)
Time frame: 6 and a half 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 19 Dec 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.
Philippe RYVLIN, MD principal investigator
Sercie de neurologie fonctionnelle et d'epileptologie, Hôpital Neurologique Pierre Wertheimer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-resistant Partial Epilepsy, run by Hospices Civils de Lyon at 1 site 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 6 inclusion and 4 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 19 Dec 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 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?
Number of patients with SpO2 < 80% decreases during the EEG-video monitoring (time frame: 6 and a half 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 19 Dec 2025.