Risk Factors for Sudden Unexplained Death in Epilepsy

SUDEP Clinical Trial

— SUDEP  

Official title:

Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01662453
• Other study ID #: 11-01664
• Status: Recruiting
• Start date: June 2011
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Juliana Laze
• Phone: 646-558-0835
• Email: Juliana.laze[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• SUDEP

Locations

Country	Name	City	State
United States	NYU Comprehensive Epilepsy Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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