SUDEPSUDEPNCT01662453
Risk Factors for Sudden Unexplained Death in Epilepsy
An observational study of SUDEP, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SUDEP
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Comprehensive Epilepsy Center
New York, New York, 10016
Juliana Laze, 646-558-0835, Juliana.laze@nyulangone.org
Orrin Devinsky, MD
About this study
Official title: Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)
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.
Read the 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.
- Conditions
- SUDEP
- Keywords
- epilepsy, seizures, mortality, sudep, risk factors
- Medical subject headings
- Sudden Unexpected Death in Epilepsy, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJun 2011
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SUDEPStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Orrin Devinsky, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662453
- Sponsor's protocol ID
- 11-01664
- Acronym
- SUDEP
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2012
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)
- ClinicalTrials.gov ID
- NCT01662453
- Acronym / sponsor ID
- SUDEP / 11-01664
- Conditions
- SUDEP
- Keywords
- epilepsy, seizures, mortality, sudep, risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Orrin Devinsky, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SUDEP, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Laze (646-558-0835, Juliana.laze@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Incidence of SUDEP - Risk factors for SUDEP. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.