Drug-resistant Partial Epilepsy Clinical Trial
— REPOMSEOfficial title:
National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
| Verified date | June 2017 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 1072 |
| Est. completion date | August 23, 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Pierre Wertheimer, Hospices Civils de Lyon | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 and a half months | |
| Secondary | 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. | 6 and a half months | |
| Secondary | 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. | 6 and a half months |