Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01662453
Recruitment Status : Recruiting
First Posted : August 10, 2012
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:

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.

Condition or disease

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.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)
Study Start Date : June 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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.

Primary Outcome Measures :
  1. - Incidence of SUDEP - Risk factors for SUDEP. [ Time Frame: 3 years ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01662453

Contact: Ben Kaufman 646-558-0818
Contact: Jane Kwon 646-558-0841

United States, New York
NYU Comprehensive Epilepsy Center Recruiting
New York, New York, United States, 10016
Contact: Kyra Doumlele    646-558-0818   
Contact: Jane Kwon    646-558-0841   
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Orrin Devinsky, MD NYU School of Medicine

Responsible Party: New York University School of Medicine Identifier: NCT01662453     History of Changes
Other Study ID Numbers: 11-01664
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases