Risk Factors of SUDEP

NCT03074279 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 408

Last updated 2017-03-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • French Foundation for Epilepsy Research (FFRE)

    collaborator UNKNOWN
  • The French League Against Epilepsy (LFCE)

    collaborator UNKNOWN
  • University Hospital, Bordeaux

    collaborator OTHER
  • University Hospital, Lille

    collaborator OTHER
  • Hospices Civils de Lyon

    collaborator OTHER
  • University Hospital, Marseille

    collaborator OTHER
  • Central Hospital, Nancy, France

    collaborator OTHER
  • Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré)

    collaborator UNKNOWN
  • Rennes University Hospital

    collaborator OTHER
  • University Hospital, Strasbourg, France

    collaborator OTHER
  • ToulouseUniversity Hospital

    collaborator UNKNOWN
  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Marie-Christine Picot, MD, PhD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-01
Primary Completion
2017-12-31
Completion
2018-07-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074279 on ClinicalTrials.gov