xml: <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/NCT05982717</url>
    </required_header>
    <id_info>
      <org_study_id>TAK-935-5003</org_study_id>
      <nct_id>NCT05982717</nct_id>
    </id_info>
    <brief_title>A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain</brief_title>
    <acronym>DRALEGA</acronym>
    <official_title>Epidemiology of Dravet and Lennox-Gastaut Syndromes in Spain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Takeda</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Takeda</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main aims of this study are to gather information about how many children, teenagers and&#xD;
        adults in Spain have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome as well&#xD;
        as to learn about the number of new Dravet syndrome and Lennox-Gastaut syndrome cases in&#xD;
        persons in Spain.&#xD;
  &#xD;
        Participants' data will be taken from their medical records (charts), which were already&#xD;
        collected as a part of their routine care in public hospitals in Spain between 01 January&#xD;
        2021 and 31 December 2022.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a non-interventional, retrospective study of participants from Spain with DS and LGS&#xD;
        at public hospitals. The participants will be identified from their medical charts or&#xD;
        hospital records and those who meet the eligibility criteria will be included.&#xD;
  &#xD;
        This multi-center trial will be conducted in Spain. Data will be retrospectively collected&#xD;
        for the observation period between 01 January 2021 to 31 December 2022. The total duration of&#xD;
        the study is approximately 24 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>One-Year Period Prevalence of DS</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Number of participants with DS over a period of one year will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of DS</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Number of new participants diagnosed annually with DS yearly.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>One-Year Period Prevalence of LGS Based on Stricter Diagnosis Criterion</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Number of participants with LGS over a period of one year based on stricter diagnosis criterion will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of LGS Based on Stricter Diagnosis Criterion</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Number of new participants diagnosed annually with LGS based on stricter diagnosis criterion.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>One-Year Period Prevalence of LGS Based on Wider Diagnosis Criterion</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Number of participants with LGS over a period of one year based on wider diagnosis criterion will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of LGS Based on Wider Diagnosis Criterion</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Number of new participants diagnosed annually with LGS based on wider diagnosis criterion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-Year Period Prevalence of Paediatric DS</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Number of participants with paediatric DS over a period of one year will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-Year Period Prevalence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Number of participants with paediatric LGS over a period of one year based on stricter and wider diagnoses criteria will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-Year Period Prevalence of Adult DS</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Number of participants with adult DS over a period of one year will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-Year Period Prevalence of Adult LGS Based on Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>Up to 12 months</time_frame>
      <description>Number of participants with adult LGS over period of one year based on stricter and wider diagnoses criteria will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Paediatric DS</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Number of new paediatric participants diagnosed annually with DS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Number of new paediatric participants diagnosed annually with LGS based on stricter and wider diagnoses criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Adult DS</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Number of new adult participants diagnosed annually with DS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Adult LGS Based on Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Number of new adult participants diagnosed annually with LGS based on stricter and wider diagnoses criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DS Categorized Based on Gender Distribution</measure>
      <time_frame>Up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LGS Categorized Based on Gender Distribution According to Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>Up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DS Categorized Based on Age Distribution</measure>
      <time_frame>Up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LGS Categorized Based on Age Distribution According to Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>Up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DS Categorized Based on Gender Distribution at Diagnosis</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed DS participants will be categorized based on gender distribution at diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LGS Categorized Based on Gender Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed LGS participants will be categorized based on gender distribution at diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DS Categorized Based on Age Distribution at Diagnosis</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed DS participants will be categorized based on age distribution at diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LGS Categorized Based on Age Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed LGS participants will be categorized based on age distribution at diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DS Categorized Based on Gender Distribution at Symptoms Onset</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed DS participants will be categorized based on gender distribution at symptoms onset.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LGS Categorized Based on Gender Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed LGS participants will be categorized based on gender distribution at symptoms onset.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DS Categorized Based on Age Distribution at Symptoms Onset</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed DS participants will be categorized based on age distribution at symptoms onset.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LGS Categorized Based on Age Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Annually diagnosed LGS participants will be categorized based on age distribution at symptoms onset.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnosis Delay for Participants With DS</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Diagnosis delay is defined as time from symptoms onset to diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnosis Delay for Participants With LGS Based on Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
      <description>Diagnosis delay is defined as time from tonic seizures onset to electroencephalography (EEG) confirmation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participants With DS: Ratio of Participants Genetically (Sodium Channel Protein Type 1 Subunit Alpha [SCN1A] Mutation) and Clinically Diagnosed Versus Participants Clinically Diagnosed Only</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participants With LGS: Number of Participants Distributed According to Aetiologies Based on Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participants With DS: Number of Participants With Different Types of Comorbidities at Diagnosis</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participants With LGS: Number of Participants With Different Types of Comorbidities at Diagnosis Based on Stricter and Wider Diagnoses Criteria</measure>
      <time_frame>At two different 12 month periods (in consecutive years at Months 12 and 24)</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Dravet Syndrome (DS)</condition>
    <condition>Lennox-Gastaut Syndrome (LGS)</condition>
    <arm_group>
      <arm_group_label>Participants With DS or LGS</arm_group_label>
      <description>Participants with a medical record of diagnosis with either DS or LGS that are treated in the participating hospitals and reside in the reference area of these hospitals will be included and data will be retrospectively collected for the period between 01 January 2021 to 31 December 2022.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>As this is an observational study, no intervention will be administered.</description>
      <arm_group_label>Participants With DS or LGS</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants diagnosed with DS or LGS at public hospitals in Spain will be enrolled in the&#xD;
          study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A. Diagnosis criteria for DS:&#xD;
  &#xD;
          • All the following criteria must be met: i. Seizures onset within 1-20 months (usually&#xD;
          within the first year of life). ii. Normal initial development prior to presentation (no&#xD;
          cognitive or behavioural disability before the onset of seizures) followed by behaviour and&#xD;
          cognitive impairment.&#xD;
  &#xD;
          iii. Recurrent focal clonic (hemiclonic) febrile and afebrile seizures (which often&#xD;
          alternate sides from seizure to seizure), focal to bilateral tonicclonic, and/or&#xD;
          generalized clonic seizures.&#xD;
  &#xD;
          • And at least one of the following criteria must be met: i. Emergence of other seizure&#xD;
          type, including atypical absence seizures, myoclonic seizures, atonic seizures, or&#xD;
          non-tonic-clonic status epilepticus between 1-4 years.&#xD;
  &#xD;
          ii. Seizures triggered by fever due to illness or vaccinations, hot baths, sudden&#xD;
          temperature changes, high level of activity, or by strong lighting or exposure to certain&#xD;
          visual patterns.&#xD;
  &#xD;
          iii. Mutations or copy number variants in the SCN1A gene.&#xD;
  &#xD;
          B. Diagnosis criteria for LGS:&#xD;
  &#xD;
          Given the uncertainties associated with the diagnosis of this condition, two different&#xD;
          criteria will be used, a stricter criterion, intended to identify &quot;pure&quot; Lennox-Gastaut&#xD;
          syndrome participants, and a wider criterion, intended to also include the so-called&#xD;
          Lennox-Gastaut-like participants.&#xD;
  &#xD;
          Lennox-Gastaut syndrome - stricter criteria:&#xD;
  &#xD;
          • All the following criteria must be met: i. Seizures onset before 18 years of age,&#xD;
          typically from 1 to 8 years. ii. Progressive development/cognition impairment after&#xD;
          seizures onset. iii. Tonic seizures. iv. At least one additional seizure: generalised&#xD;
          tonic-clonic seiures, atypical absence seizures, atonic seizures, myoclonic seizures, focal&#xD;
          impaired awareness, epileptic spams, or non-convulsive status epilepticus v. Slow (&lt;2.5&#xD;
          hertz [Hz]) spike-and-wave EEG pattern. vi. Paroxysmal fast activity (10 Hz or greater) in&#xD;
          sleep.&#xD;
  &#xD;
          Lennox-Gastaut syndrome - wider criteria:&#xD;
  &#xD;
            -  At least one the following criteria must be met:&#xD;
  &#xD;
               i. Tonic seizures. ii. Multiple types of seizures, including generalised tonic-clonic&#xD;
               seizures, atypical absence seizures, atonic seizures, myoclonic seizures,&#xD;
               myoclonic-atonic seizures, focal seizures, epileptic spams, or nonconvulsive status&#xD;
               epilepticus.&#xD;
  &#xD;
            -  And at least one the following criteria must be met:&#xD;
  &#xD;
               i. Slow (&lt;2.5 Hz) spike-and-wave EEG pattern. ii. Paroxysmal fast activity (10 Hz or&#xD;
               greater) in sleep.&#xD;
  &#xD;
            -  And at least two of the following criteria must be met:&#xD;
  &#xD;
               i. Seizures onset before 18 years of age, typically from 1 to 8 years. ii. Progressive&#xD;
               development/cognition impairment after seizures onset. iii. Development/cognition&#xD;
               impairment starts prior to seizures onset. iv. History of Infantile epileptic spasms&#xD;
               syndrome (IESS), West or Ohtahara syndromes.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            1. Participants with epileptic condition other than DS or LGS.&#xD;
  &#xD;
            2. Participants with DS or LGS not residents in the reference area of the hospital.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Study Director</last_name>
      <role>Study Director</role>
      <affiliation>Takeda</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Takeda Contact</last_name>
      <phone>+1-877-825-3327</phone>
      <email>medinfoUS@takeda.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Universitari i Politècnic La Fe</name>
        <address>
          <city>Valencia</city>
          <zip>46026</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site Contact</last_name>
        <phone>+34 961244161</phone>
        <email>vevillanuevah@yahoo.es</email>
      </contact>
      <investigator>
        <last_name>Vicente Enrique Villanueva Haba</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Drug Therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epilepsies, Myoclonic</mesh_term>
      <mesh_term>Lennox Gastaut Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982717
  org study id: TAK-935-5003
  nct id: NCT05982717
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main aims of this study are to gather information about how many children, teenagers and
        adults in Spain have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome as well
        as to learn about the number of new Dravet syndrome and Lennox-Gastaut syndrome cases in
        persons in Spain.
  
        Participants' data will be taken from their medical records (charts), which were already
        collected as a part of their routine care in public hospitals in Spain between 01 January
        2021 and 31 December 2022.
  This is a non-interventional, retrospective study of participants from Spain with DS and LGS
        at public hospitals. The participants will be identified from their medical charts or
        hospital records and those who meet the eligibility criteria will be included.
  
        This multi-center trial will be conducted in Spain. Data will be retrospectively collected
        for the observation period between 01 January 2021 to 31 December 2022. The total duration of
        the study is approximately 24 months.
  observational model: Case-Only
  time perspective: Retrospective
  measure: One-Year Period Prevalence of DS
  time frame: Up to 12 months
  description: Number of participants with DS over a period of one year will be assessed.
  measure: Incidence of DS
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Number of new participants diagnosed annually with DS yearly.
  measure: One-Year Period Prevalence of LGS Based on Stricter Diagnosis Criterion
  time frame: Up to 12 months
  description: Number of participants with LGS over a period of one year based on stricter diagnosis criterion will be assessed.
  measure: Incidence of LGS Based on Stricter Diagnosis Criterion
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Number of new participants diagnosed annually with LGS based on stricter diagnosis criterion.
  measure: One-Year Period Prevalence of LGS Based on Wider Diagnosis Criterion
  time frame: Up to 12 months
  description: Number of participants with LGS over a period of one year based on wider diagnosis criterion will be assessed.
  measure: Incidence of LGS Based on Wider Diagnosis Criterion
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Number of new participants diagnosed annually with LGS based on wider diagnosis criterion.
  measure: One-Year Period Prevalence of Paediatric DS
  time frame: Up to 12 months
  description: Number of participants with paediatric DS over a period of one year will be assessed.
  measure: One-Year Period Prevalence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria
  time frame: Up to 12 months
  description: Number of participants with paediatric LGS over a period of one year based on stricter and wider diagnoses criteria will be assessed.
  measure: One-Year Period Prevalence of Adult DS
  time frame: Up to 12 months
  description: Number of participants with adult DS over a period of one year will be assessed.
  measure: One-Year Period Prevalence of Adult LGS Based on Stricter and Wider Diagnoses Criteria
  time frame: Up to 12 months
  description: Number of participants with adult LGS over period of one year based on stricter and wider diagnoses criteria will be assessed.
  measure: Incidence of Paediatric DS
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Number of new paediatric participants diagnosed annually with DS.
  measure: Incidence of Paediatric LGS Based on Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Number of new paediatric participants diagnosed annually with LGS based on stricter and wider diagnoses criteria.
  measure: Incidence of Adult DS
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Number of new adult participants diagnosed annually with DS.
  measure: Incidence of Adult LGS Based on Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Number of new adult participants diagnosed annually with LGS based on stricter and wider diagnoses criteria.
  measure: DS Categorized Based on Gender Distribution
  time frame: Up to 12 months
  measure: LGS Categorized Based on Gender Distribution According to Stricter and Wider Diagnoses Criteria
  time frame: Up to 12 months
  measure: DS Categorized Based on Age Distribution
  time frame: Up to 12 months
  measure: LGS Categorized Based on Age Distribution According to Stricter and Wider Diagnoses Criteria
  time frame: Up to 12 months
  measure: DS Categorized Based on Gender Distribution at Diagnosis
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed DS participants will be categorized based on gender distribution at diagnosis.
  measure: LGS Categorized Based on Gender Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed LGS participants will be categorized based on gender distribution at diagnosis.
  measure: DS Categorized Based on Age Distribution at Diagnosis
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed DS participants will be categorized based on age distribution at diagnosis.
  measure: LGS Categorized Based on Age Distribution at Diagnosis According to Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed LGS participants will be categorized based on age distribution at diagnosis.
  measure: DS Categorized Based on Gender Distribution at Symptoms Onset
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed DS participants will be categorized based on gender distribution at symptoms onset.
  measure: LGS Categorized Based on Gender Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed LGS participants will be categorized based on gender distribution at symptoms onset.
  measure: DS Categorized Based on Age Distribution at Symptoms Onset
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed DS participants will be categorized based on age distribution at symptoms onset.
  measure: LGS Categorized Based on Age Distribution at Symptoms Onset According to Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Annually diagnosed LGS participants will be categorized based on age distribution at symptoms onset.
  measure: Diagnosis Delay for Participants With DS
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Diagnosis delay is defined as time from symptoms onset to diagnosis.
  measure: Diagnosis Delay for Participants With LGS Based on Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  description: Diagnosis delay is defined as time from tonic seizures onset to electroencephalography (EEG) confirmation.
  measure: Participants With DS: Ratio of Participants Genetically (Sodium Channel Protein Type 1 Subunit Alpha [SCN1A] Mutation) and Clinically Diagnosed Versus Participants Clinically Diagnosed Only
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  measure: Participants With LGS: Number of Participants Distributed According to Aetiologies Based on Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  measure: Participants With DS: Number of Participants With Different Types of Comorbidities at Diagnosis
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  measure: Participants With LGS: Number of Participants With Different Types of Comorbidities at Diagnosis Based on Stricter and Wider Diagnoses Criteria
  time frame: At two different 12 month periods (in consecutive years at Months 12 and 24)
  arm group label: Participants With DS or LGS
  description: Participants with a medical record of diagnosis with either DS or LGS that are treated in the participating hospitals and reside in the reference area of these hospitals will be included and data will be retrospectively collected for the period between 01 January 2021 to 31 December 2022.
  intervention type: Other
  intervention name: No intervention
  description: As this is an observational study, no intervention will be administered.
  arm group label: Participants With DS or LGS
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Study Director
  role: Study Director
  affiliation: Takeda
  last name: Takeda Contact
  phone: +1-877-825-3327
  email: medinfoUS@takeda.com
  facility: 
  contact: 
  investigator: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Epilepsies, Myoclonic
  mesh term: Lennox Gastaut Syndrome
  mesh term: Syndrome
  sharing ipd: Yes
  ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
  ipd url: https://vivli.org/ourmember/takeda/