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Risk Factors of SUDEP (PRERIES)

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: NCT03074279
Recruitment Status : Unknown
Verified March 2017 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Sponsor:
Collaborators:
French Foundation for Epilepsy Research (FFRE)
The French League Against Epilepsy (LFCE)
University Hospital, Bordeaux
University Hospital, Lille
Hospices Civils de Lyon
Marseille University Hospital
Nancy University Hospital
Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré)
Rennes University Hospital
Strasbourg University Hospital
ToulouseUniversity Hospital
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.

This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.


Condition or disease Intervention/treatment
Epilepsy Other: Interview with a psychologist and self-reported questionnaires

Detailed Description:

Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.

A French national network on epilepsy related death (Reseau Sentinelle Mortalité Epilepsie, RSME) will be initially established in 2010 by the French League Against Epilepsy (LFCE) under the leadership of bereaved families and supported by the French Foundation for Epilepsy Research (FFRE). This epidemiological study is based on the RSME.

The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.

The study design is an epidemiological case-control study. The cases are SUDEP identified in the RSME and French centres of Epileptology.

Epilepsy-related deaths are reported by physicians but also by bereaved families. An interview with a psychologist will be proposed at this moment.

The control group will include patients with epilepsy and relatives of patients from tertiary epilepsy units (in particular, participants of GRENAT registry or a national multicenter study RESPOMSE), private neurologists or general practitioners and thanks from patients associations.

Sociodemographic data, lifestyle, personal and family medical history will be collected during an interview with a psychologist by phone or during a face to face interview. For bereaved families, information on causes and circumstances of beloved one's death will be collected during these interviews.The characteristics of epilepsy will be completed by the patient's neurologist.

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Study Type : Observational
Estimated Enrollment : 408 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study
Actual Study Start Date : July 1, 2011
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Cases
Patient with epilepsy who died as a result of confirmed or probable SUDEP and NEAR SUDEP during the study period.
Other: Interview with a psychologist and self-reported questionnaires
The family members or patients who decide to participate in the study will be asked to complete an interview with a psychologist (semistructured interview, standard form, questionnaires) and self-reported questionnaires

Controls
Patient with epilepsy matched by: âge, etiology and type of epilepsy, level of seizure control
Other: Interview with a psychologist and self-reported questionnaires
The family members or patients who decide to participate in the study will be asked to complete an interview with a psychologist (semistructured interview, standard form, questionnaires) and self-reported questionnaires




Primary Outcome Measures :
  1. Risk factors for SUDEP [ Time Frame: 1 day ]
    • Lifestyle (night-time supervision ...), habits (alcohol consumption ...)
    • Personal cardiac history (arrhythmias, ECG abnormalities ...), respiratory, sleep apnoea, muscular or neurological disorders, mental retardation, associated psychiatric disorders…
    • Antiepileptic drugs


Secondary Outcome Measures :
  1. Familial Risk factors for SUDEP [ Time Frame: 1 day ]
    Family history of epilepsy, Family history of sudden death, arrhythmias, sleep apnea

  2. Needs and expectations of bereaved families on epilepsy related death information [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cases : Confirmed or probable SUDEP or nearSUDEP reported by physicians of the "Réseau Sentinelle Mortalité Epilepsie" (RSME) or by bereaved families. The bereaved families will be contacted by a psychologist who proposes an interview.

Controls : Patients with epilepsy and relatives of patients recruited from tertiary epilepsy units, private neurologists or general practitioners and thanks from patients associations.

Criteria

Inclusion Criteria:

Cases : Any patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years who died as a result of confirmed or probable SUDEP or NEAR SUDEP during the study period.

Controls : Patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years and matched by: age, epileptic syndrom and level of seizure controls

Exclusion Criteria:

For cases and controls :patient not living in France, refusal of participation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074279


Contacts
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Contact: Marie-Christine Picot, MD, PhD 467338978 ext 33 mc-picot@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Marie Christine Picot, MD, phD    467338978 ext 33    mc-picot@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
French Foundation for Epilepsy Research (FFRE)
The French League Against Epilepsy (LFCE)
University Hospital, Bordeaux
University Hospital, Lille
Hospices Civils de Lyon
Marseille University Hospital
Nancy University Hospital
Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré)
Rennes University Hospital
Strasbourg University Hospital
ToulouseUniversity Hospital
Investigators
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Study Director: Marie-Christine Picot, MD, PhD University Hospital, Montpellier

Publications:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03074279    
Other Study ID Numbers: 8601
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Epilepsy
SUDEP
case-control study
risks factors
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases