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National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies (REPOMSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572297
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date September 4, 2015
First Posted Date October 8, 2015
Last Update Posted Date June 20, 2017
Actual Study Start Date May 18, 2010
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02572297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 19, 2017)
  • 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 ]
    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.
  • Allelic frequency of genes involved in epileptogenesis (measured as percentage) [ Time Frame: 6 and a half months ]
    Evaluation of the genetic polymorphism of the monoaminergic system or of genes involved in the early epilepsy stage mechanisms of early stages of epilepsy.
Original Secondary Outcome Measures
 (submitted: October 7, 2015)
  • Frequence of other known potential risk factors (measured as percentage) [ Time Frame: 6 and a half months ]
    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).
  • Allelic frequency of genes involved in epileptogenesis (measured as percentage) [ Time Frame: 6 and a half months ]
    Evaluation of the genetic polymorphism of the monoaminergic system or of genes involved in the early epilepsy stage mechanisms of early stages of epilepsy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
Official Title National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
Brief 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). 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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition Drug-resistant Partial Epilepsy
Intervention Other: video-EEG
Registration of seizures during video-EEG
Study Groups/Cohorts 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
Intervention: Other: video-EEG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 7, 2015)
1072
Original Actual Enrollment Same as current
Actual Study Completion Date August 23, 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02572297
Other Study ID Numbers 2009.582
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Philippe RYVLIN, MD Sercie de neurologie fonctionnelle et d'epileptologie, Hôpital Neurologique Pierre Wertheimer
PRS Account Hospices Civils de Lyon
Verification Date June 2017