PRERIES: Risk Factors of SUDEP

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT03074279

Collaborator

French Foundation for Epilepsy Research (FFRE) (Other), The French League Against Epilepsy (LFCE) (Other), University Hospital, Bordeaux (Other), University Hospital, Lille (Other), Hospices Civils de Lyon (Other), University Hospital, Marseille (Other), Central Hospital, Nancy, France (Other), Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré) (Other), Rennes University Hospital (Other), University Hospital, Strasbourg, France (Other), ToulouseUniversity Hospital (Other)

408

Enrollment

Location

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Epilepsy	Other: Interview with a psychologist and self-reported questionnaires

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jul 1, 2011

Anticipated Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Jul 31, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Risk factors for SUDEP [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

Familial Risk factors for SUDEP [1 day]
Family history of epilepsy, Family history of sudden death, arrhythmias, sleep apnea
Needs and expectations of bereaved families on epilepsy related death information [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Investigators

Study Director: Marie-Christine Picot, MD, PhD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT03074279

Other Study ID Numbers:

8601

First Posted:

Mar 8, 2017

Last Update Posted:

Mar 8, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Additional relevant MeSH terms: