Clinical trial NCT03074279: Risk Factors of SUDEP
Official title: Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Epilepsy
SUDEP
case-control study
risks factors
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: French Foundation for Epilepsy Research (FFRE)
name: The French League Against Epilepsy (LFCE)
name: University Hospital, Bordeaux
name: University Hospital, Lille
name: Hospices Civils de Lyon
name: University Hospital, Marseille
name: Central Hospital, Nancy, France
name: Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré)
name: Rennes University Hospital
name: University Hospital, Strasbourg, France
name: ToulouseUniversity Hospital
First posted: 2017-03-08
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Risk factors for SUDEP
timeFrame: 1 day
Secondary outcomes:
measure: Familial Risk factors for SUDEP
timeFrame: 1 day
measure: Needs and expectations of bereaved families on epilepsy related death information
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Marie-Christine Picot, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Donner EJ, Waddell B, Osland K, Leach JP, Duncan S, Nashef L, Picot MC. After sudden unexpected death in epilepsy: Lessons learned and the road forward. Epilepsia. 2016 Jan;57 Suppl 1:46-53. doi: 10.1111/epi.13235.