Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by New York University School of Medicine
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
First received: August 2, 2012
Last updated: October 5, 2015
Last verified: October 2015

The main purpose of this study is to develop a North American registry for SUDEP cases; requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to contact the study team. The family members who decide to participate in the study will be asked to complete a brief telephone interview about their loved one's epilepsy and seizure history and the circumstances of his or her death. If the death has occurred within the past 24 hours, and the family is willing to consider donating tissue to the study, the subject will be transferred to the Autism Tissue Program, and the remainder of the phone interview will be conducted at a later time.

In addition to the phone interview, the family will be asked to provide access to the deceased's medical records. Any costs involved in obtaining medical records will be covered by the study, and all medical information will remain completely confidential.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)

Resource links provided by NLM:

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • - Incidence of SUDEP - Risk factors for SUDEP. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Number of incidents of sudden unexplained deaths in epilepsy patients (SUDEP) and types of risk factors for SUDEP.

Biospecimen Retention:   Samples With DNA
If the family is willing to donate tissue, the family's permission is recorded in writing and it is filed in the subject's study record. The family can contact Autism Tissue Program (ATP) themselves or we will transfer the call to the ATP for them. The ATP has a 24/7 on call duty in place to receive new donors. The ATP coordinator will facilitate the donation process by coordinating with the family, medical examiner's office or hospital. The coordinator will also communicate to the research assistant when the donation is complete. In the case the participant does not want to donate tissue, but would like to donate other DNA samples, they will be able to do so through the NYU Biorepository. The participant will be consented, by research personnel, with the specific DNA collection consent form. Mucosal swaps or blood samples will be collected if available, if neither is available, we will collect hair or nails.

Estimated Enrollment: 400
Study Start Date: June 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
The SUDEP group refers to epileptic patients that had a sudden unexplained death; excludes trauma, drowning, status epilepticus, or other known cause, but there is often evidence of an associated seizure.
Control Group
We will recruit living patients with epilepsy for the control group. In particular, epileptic patients with Dravet Syndrome of Idic 15.

Detailed Description:

SUDEP stands for sudden unexplained death in epilepsy; a witnessed or unwitnessed, non-traumatic and non-drowning death occurring in benign circumstances, in a person with epilepsy with or without evidence of a seizure and excluding documented status epileptics (seizure duration of 130mins or longer, or seizures without recovery in between), in which a postmortem examination does not reveal a cause of death. SUDEP is not a cause of death so much as it is a descriptive term for a category of unexplained deaths in people with epilepsy or epilepsy-related conditions. Little is known about SUDEP and its mechanisms and risk factors.

One of the main objectives of this study is to investigate the role of various risk factors in the development of sudden unexplained death in patients with epilepsy, with a particular focus on the role of antiepileptic medications. In addition, we want to elucidate the pathophysiologic mechanisms leading to SUDEP.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The SUDEP group consists of epileptic patients who had a sudden unexplainable death excluding trauma, drowning, status epilepticus, or other known cause, but there is often evidence of an associated seizure.

Inclusion Criteria Sudep Group Subjects diagnosed with epilepsy whose cause of death was sudden and unexplained, and whose families are willing to participate, will be included in the study.

Control Group For the control group, we will include any patient diagnosed with epilepsy currently in the care of the NYU Comprehensive Epilepsy Center, willing and able to participate in the study.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662453

Contact: Ben Kaufman 646-558-0818 benjamin.kaufman@nyumc.org
Contact: Jane Kwon 646-558-0841 jane.kwon@nyumc.org

United States, New York
NYU Comprehensive Epilepsy Center Recruiting
New York, New York, United States, 10016
Contact: Kyra Doumlele    646-558-0818    kyra.doumlele@nyumc.org   
Contact: Jane Kwon    646-558-0841    jane.kwon@nyumc.org   
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Orrin Devinsky, MD NYU School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01662453     History of Changes
Other Study ID Numbers: 11-01664
Study First Received: August 2, 2012
Last Updated: October 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
risk factors

ClinicalTrials.gov processed this record on November 27, 2015