Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT01662453

Conditions

SUDEP

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT01662453

Start date

Jun, 2011

Status verified date

Jun, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • - Incidence of SUDEP - Risk factors for SUDEP. [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

NYU Comprehensive Epilepsy Center

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Orrin Devinsky, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • epilepsy
  • seizures
  • mortality
  • sudep
  • risk factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-04.