Risk Factors for Sudden Unexplained Death in Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)

NCT02788318

Sudden Unexpected Death in Epilepsy (SUDEP)

TERMINATED

National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies

NCT02572297

Drug-resistant Partial Epilepsy

COMPLETED

Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients With Epilepsy

NCT02332447

Epilepsy

COMPLETED PHASE3

Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY

NCT03419000

Drug Resistant Epilepsy

COMPLETED NA

Assessment of Suicidality in Epilepsy - Rating Tools

NCT01085461

Epilepsy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SUDEP

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Control Group

We will recruit living patients with epilepsy for the control group. In particular, epileptic patients with Dravet Syndrome of Idic 15.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes