Risk Factors of SUDEP

Epilepsy Clinical Trial

— PRERIES  

Official title:

Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03074279
• Other study ID #: 8601
• Status: Recruiting
• Phase: N/A
• First received: March 3, 2017
• Last updated: March 3, 2017
• Start date: July 1, 2011
• Est. completion date: July 31, 2018

Study information

• Verified date: March 2017
• Source: University Hospital, Montpellier
• Contact: Marie-Christine Picot, MD, PhD
• Phone: 467338978
• Email: mc-picot[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: July 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (12)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Bordeaux University Hospital, French Foundation for Epilepsy Research (FFRE), Lyon University Hospital, Marseille University Hospital, Nancy University Hospital, Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré), Rennes University Hospital, Strasbourg University Hospital, The French League Against Epilepsy (LFCE), ToulouseUniversity Hospital, University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors for SUDEP	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	1 day
Secondary	Familial Risk factors for SUDEP	Family history of epilepsy, Family history of sudden death, arrhythmias, sleep apnea	1 day
Secondary	Needs and expectations of bereaved families on epilepsy related death information		1 day

External Links

•   RSME website