Risk Factors for Sudden Unexplained Death in Epilepsy

NCT01662453 | Recruiting

• 1 other identifier: 11-01664
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

SUDEP

Keywords

epilepsy; seizures; mortality; sudep; risk factors

Outcome Measures

Primary Outcomes (1)

• - Incidence of SUDEP - Risk factors for SUDEP.

  Number of incidents of sudden unexplained deaths in epilepsy patients (SUDEP) and types of risk factors for SUDEP.

  3 years

Study Arms (2)

SUDEP Group

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Comprehensive Epilepsy Center

New York, New York, 10016, United States

RECRUITING

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.

MeSH Terms

Conditions

Sudden Unexpected Death in Epilepsy; Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Orrin Devinsky, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Laze

CONTACT

646-558-0835; Juliana.laze@nyulangone.org

Marlene Cosme

CONTACT

646-558-0840; marlene.cosme@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 10, 2012
• Study Start: June 1, 2011
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

US (1)