<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01662453</url>
  </required_header>
  <id_info>
    <org_study_id>11-01664</org_study_id>
    <nct_id>NCT01662453</nct_id>
  </id_info>
  <brief_title>Risk Factors for Sudden Unexplained Death in Epilepsy</brief_title>
  <acronym>SUDEP</acronym>
  <official_title>Risk Factors for Sudden Unexplained Death in Epilepsy (SUDEP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to develop a North American registry for SUDEP cases;&#xD;
      requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to&#xD;
      contact the study team. The family members who decide to participate in the study will be&#xD;
      asked to complete a brief telephone interview about their loved one's epilepsy and seizure&#xD;
      history and the circumstances of his or her death. If the death has occurred within the past&#xD;
      24 hours, and the family is willing to consider donating tissue to the study, the subject&#xD;
      will be transferred to the Autism Tissue Program, and the remainder of the phone interview&#xD;
      will be conducted at a later time.&#xD;
&#xD;
      In addition to the phone interview, the family will be asked to provide access to the&#xD;
      deceased's medical records. Any costs involved in obtaining medical records will be covered&#xD;
      by the study, and all medical information will remain completely confidential.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SUDEP stands for sudden unexplained death in epilepsy; a witnessed or unwitnessed,&#xD;
      non-traumatic and non-drowning death occurring in benign circumstances, in a person with&#xD;
      epilepsy with or without evidence of a seizure and excluding documented status epileptics&#xD;
      (seizure duration of 130mins or longer, or seizures without recovery in between), in which a&#xD;
      postmortem examination does not reveal a cause of death. SUDEP is not a cause of death so&#xD;
      much as it is a descriptive term for a category of unexplained deaths in people with epilepsy&#xD;
      or epilepsy-related conditions. Little is known about SUDEP and its mechanisms and risk&#xD;
      factors.&#xD;
&#xD;
      One of the main objectives of this study is to investigate the role of various risk factors&#xD;
      in the development of sudden unexplained death in patients with epilepsy, with a particular&#xD;
      focus on the role of antiepileptic medications. In addition, we want to elucidate the&#xD;
      pathophysiologic mechanisms leading to SUDEP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>- Incidence of SUDEP - Risk factors for SUDEP.</measure>
    <time_frame>3 years</time_frame>
    <description>Number of incidents of sudden unexplained deaths in epilepsy patients (SUDEP) and types of risk factors for SUDEP.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">700</enrollment>
  <condition>SUDEP</condition>
  <arm_group>
    <arm_group_label>SUDEP Group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>We will recruit living patients with epilepsy for the control group. In particular, epileptic patients with Dravet Syndrome of Idic 15.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      If the family is willing to donate tissue, the family's permission is recorded in writing and&#xD;
      it is filed in the subject's study record. The family can contact Autism Tissue Program (ATP)&#xD;
      themselves or we will transfer the call to the ATP for them. The ATP has a 24/7 on call duty&#xD;
      in place to receive new donors. The ATP coordinator will facilitate the donation process by&#xD;
      coordinating with the family, medical examiner's office or hospital. The coordinator will&#xD;
      also communicate to the research assistant when the donation is complete. In the case the&#xD;
      participant does not want to donate tissue, but would like to donate other DNA samples, they&#xD;
      will be able to do so through the NYU Biorepository. The participant will be consented, by&#xD;
      research personnel, with the specific DNA collection consent form. Mucosal swaps or blood&#xD;
      samples will be collected if available, if neither is available, we will collect hair or&#xD;
      nails.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The SUDEP group consists of epileptic patients who had a sudden unexplainable death&#xD;
        excluding trauma, drowning, status epilepticus, or other known cause, but there is often&#xD;
        evidence of an associated seizure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria Sudep Group Subjects diagnosed with epilepsy whose cause of death was&#xD;
        sudden and unexplained, and whose families are willing to participate, will be included in&#xD;
        the study.&#xD;
&#xD;
        Control Group For the control group, we will include any patient diagnosed with epilepsy&#xD;
        currently in the care of the NYU Comprehensive Epilepsy Center, willing and able to&#xD;
        participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Orrin Devinsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marlene Cosme</last_name>
    <phone>646-558-0840</phone>
    <email>marlene.cosme@nyulangone.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>NYU Comprehensive Epilepsy Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juliana Laze</last_name>
      <phone>646-558-0835</phone>
      <email>Juliana.laze@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Orrin Devinsky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epilepsy</keyword>
  <keyword>seizures</keyword>
  <keyword>mortality</keyword>
  <keyword>sudep</keyword>
  <keyword>risk factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Sudden Unexpected Death in Epilepsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01662453
org study id: 11-01664
nct id: NCT01662453
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Control
time perspective: Retrospective
measure: - Incidence of SUDEP - Risk factors for SUDEP.
time frame: 3 years
description: Number of incidents of sudden unexplained deaths in epilepsy patients (SUDEP) and types of risk factors for SUDEP.
arm group label: SUDEP Group
description: 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.
arm group label: Control Group
description: We will recruit living patients with epilepsy for the control group. In particular, epileptic patients with Dravet Syndrome of Idic 15.
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.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Orrin Devinsky, MD
role: Principal Investigator
affiliation: NYU School of Medicine
last name: Marlene Cosme
phone: 646-558-0840
email: marlene.cosme@nyulangone.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Sudden Unexpected Death in Epilepsy