<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/NCT02233855</url>
  </required_header>
  <id_info>
    <org_study_id>140191</org_study_id>
    <secondary_id>14-I-0191</secondary_id>
    <nct_id>NCT02233855</nct_id>
  </id_info>
  <brief_title>People Presenting With Neurocysticercosis in North America</brief_title>
  <official_title>NACC 002: A Multicenter Prospective Natural History Study of Patients Presenting With Neurocysticercosis in North America</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Neurocysticercosis (NCC) is caused by tapeworms that infect people. NCC can lead to serious&#xD;
      brain problems such as seizures, sevre headaches and difficulties with movements or sensation&#xD;
      in the limbs. Researchers want to learn more about the different ways in which people in the&#xD;
      United States present with this disease and how they respond to standard and newer&#xD;
      treatments.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To learn about the different forms of NCC that occurs throughout North America and how&#xD;
      patients with these forms respond to treatment.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Adults age 18 or older with NCC.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with:&#xD;
&#xD;
        -  Medical history and physical exam.&#xD;
&#xD;
        -  A computed tomography (CT) brain scan The participant will lie still on a table that&#xD;
           slides into a large donut-shaped scanner.&#xD;
&#xD;
        -  Blood drawn through an arm vein for analysis&#xD;
&#xD;
        -  A magnetic resonance imaging (MRI) scan of the brain and spine. They will lay flat in a&#xD;
           long metal cylinder as the machine makes images of the body. During the scan,&#xD;
           participants will receive a contrast agent through an IV that allows high resolution&#xD;
           imaging of the brain and spine&#xD;
&#xD;
        -  Participants will visit the clinic at 0, 1, 2, 3, 6, 12, and 24 months (7 times), and&#xD;
           depending on the need for monitoring, more times. Participants will receive a schedule&#xD;
           that will explain the procedures done at each visit.&#xD;
&#xD;
        -  At these visits, participants may:&#xD;
&#xD;
        -  Repeat the screening procedures.&#xD;
&#xD;
        -  Be asked about their NCC symptoms and their physical and mental health.&#xD;
&#xD;
        -  Have a urine test.&#xD;
&#xD;
        -  Take a test of their ability to concentrate, their memory and spatial recognition.&#xD;
&#xD;
        -  Have a lumbar puncture, if indicated by the state and severity of infection. A needle&#xD;
           will be inserted through the skin and into the space between the bones in the back.&#xD;
           Cerebrospinal fluid will be removed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neurocysticercosis (NCC) is the most common helminthic CNS infection and the main cause of&#xD;
      adult-onset seizures in low-to-middle income countries. Studies have documented significant&#xD;
      endemicity in Latin America, Eastern Europe, sub-Saharan Africa, India and other parts of the&#xD;
      world. The prevalence of NCC in North America is rising as a result of increased migration of&#xD;
      people with the disease and, occasionally, immigration of individuals with asymptomatic&#xD;
      tapeworms. Despite the gains in knowledge and understanding of the epidemiology,&#xD;
      pathophysiology, diagnosis, and treatment, clinical care continues to be hampered by&#xD;
      unanswered fundamental questions related to optimal diagnosis, staging, treatment, and&#xD;
      follow-up of patients with NCC.&#xD;
&#xD;
      This multi-center, natural history study seeks to characterize: the frequency of the various&#xD;
      forms of NCC in North American populations; the spectrum of treatment and management&#xD;
      strategies across the North American Cysticercosis Consortium; and the response to therapy by&#xD;
      evaluating a number of endpoints related to disease evolution and treatment, such as burden&#xD;
      of disease, cognitive changes, radiographic changes, and treatment complications. This study&#xD;
      will inform future research studies needed to eventually establish standardized management&#xD;
      protocols for each form of this complex infection.&#xD;
&#xD;
      Subjects will have visits at screening, baseline, 1, 2 (optional), 3, 6, 12, and 24 months.&#xD;
      Evaluations will include assessment of clinical status, antigen assays, radiographic imaging,&#xD;
      functional assessments, immunologic evaluations, cognitive assessments, and quality of life&#xD;
      measures. Additional clinically indicated visits may be scheduled as needed. This study does&#xD;
      not provide any interventional therapies but will collect data on the course of treatment.&#xD;
      Diagnostic examinations, consultations and medical treatment will be determined by the study&#xD;
      clinician. Any samples removed for medical indications related to NCC may be evaluated for&#xD;
      research purposes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>September 3, 2014</start_date>
  <completion_date type="Actual">June 13, 2017</completion_date>
  <primary_completion_date type="Actual">June 13, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The heterogeneity and complexity of the different forms of NCC will make it necessary to use different endpoints in analyzing the data collected from patients with each subtype of NCC. The endpoints listed here will be tailored and applied to th...</measure>
    <time_frame>Throughout the course of the study</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To characterize the spectrum of diagnostic and treatment approaches across sites, including type and length of anthelmintic, anti-inflammatories, and anticonvulsants</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine exposure risks and estimate time to clinical symptomatic disease (incubation time) for each form of NCC</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For each form of NCC, to assess patient outcomes relative to: a) duration and type of anthelmintic therapy; b) duration and type of immunosuppressive therapy; and c) anticonvulsant therapy</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To correlate clinical features with radiographic findings at presentation, during treatment and follow-up for each form of NCC</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine proportion of patients with clinical and radiographic success 1 and 2 years after initiation of therapy. Definition of radiographic success will vary by form of NCC, but be based upon improvement followed by radiologic stability or slo...</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To enumerate complications associated with NCC or treatment type for each form of NCC</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To characterize and correlate the clinical features, radiographic findings, antigen presence and levels, and antibody responses for NCC with perilesional edema</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess diagnostic parameters of serology and antigen detection assays in North American patients</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To correlate antigen levels in serum and CSF with burden of disease and recurrence of disease in subjects with NCC</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To characterize cognitive function at baseline, 6, 12, and 24 months as assessed by the Montreal Cognitive Assessment (MOCA) test</measure>
    <time_frame>Throughout the course of the study.</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Neurocysticercosis</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Adults greater than or equal to18 years of age.&#xD;
&#xD;
               2. Subject, or Subject s Legally Authorized Representative (LAR)/ Durable Power of&#xD;
                  Attorney (DPA), is able to provide informed consent and agree to allow samples to&#xD;
                  be stored for future research.&#xD;
&#xD;
               3. Previously or currently diagnosed with definitive or probable NCC by a&#xD;
                  practitioner at NACC in accordance with the Del Brutto criteria modified for use&#xD;
                  in a North American populations.&#xD;
&#xD;
        For the purpose of this study, definitive and probable diagnostic certainty based on&#xD;
        presence of criteria below.&#xD;
&#xD;
        Definitive diagnosis&#xD;
&#xD;
          1. Presence of 1 absolute criterion&#xD;
&#xD;
          2. Presence of 2 major + 1 minor + 1 epidemiological criterion&#xD;
&#xD;
        Probable diagnosis Presence of 1 major + 2 minor criterion&#xD;
&#xD;
          1. Presence of 1 major + 1 minor + 1 epidemiological criterion&#xD;
&#xD;
          2. Presence of characteristic calcification(s)&#xD;
&#xD;
        Del Brutto Diagnostic criteria&#xD;
&#xD;
          1. Absolute criteria&#xD;
&#xD;
               1. Biopsy of a brain or spinal cord lesion&#xD;
&#xD;
               2. Cystic lesion with scolex on CT or MRI&#xD;
&#xD;
               3. Fundoscopic examination (subretinal parasites)&#xD;
&#xD;
          2. Major criteria&#xD;
&#xD;
               1. Highly suggestive lesions on neuroimaging&#xD;
&#xD;
               2. Positive serum enzyme-linked immunotransfer blot (EITB) assay&#xD;
&#xD;
               3. Resolution of intracranial cysts after therapy&#xD;
&#xD;
               4. Spontaneous resolution of small single enhancing lesions&#xD;
&#xD;
          3. Minor criteria&#xD;
&#xD;
               1. Compatible lesions on neuroimaging&#xD;
&#xD;
               2. Clinical manifestations suggestive for NCC (eg, headaches, seizures, neurological&#xD;
                  symptoms)&#xD;
&#xD;
               3. Positive CSF ELISA for specific Ag/Ab&#xD;
&#xD;
               4. Cysts outside CNS&#xD;
&#xD;
          4. Epidemiological criteria&#xD;
&#xD;
               1. Evidence of household contact with T. solium&#xD;
&#xD;
               2. Individuals coming from/living in endemic areas&#xD;
&#xD;
               3. History of frequent travel to endemic areas&#xD;
&#xD;
          5. Single or multiple characteristic calcifications in subjects who meet epidemiologic&#xD;
             criteria (4) without another identifiable etiology will be considered NCC in the case&#xD;
             of calcified granulomas&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        1. Subjects that in the opinion of the investigator have contraindications for&#xD;
        participation in the study will be excluded, such as patients with current substance abuse&#xD;
        or patients currently undergoing cancer chemotherapy.&#xD;
&#xD;
        Justification for Exclusion or Inclusion of Special Populations&#xD;
&#xD;
        Children&#xD;
&#xD;
        Children are eligible to participate in this clinical trial but will not be enrolled at the&#xD;
        NIH because the NIH investigators do not see nor specialize in pediatric populations. In&#xD;
        addition, NCC in the U.S. generally afflicts travelers and immigrants and is therefore&#xD;
        exceedingly rare in pediatric populations in the U.S.&#xD;
&#xD;
        Adults Unable To Provide Consent-&#xD;
&#xD;
        Patients will be offered standard of care treatment delivered irrespective of cognitive&#xD;
        status, including lumbar punctures that are used clinical management decisions as&#xD;
        determined by the site PI. Exclusion of patients unable to provide consent because of&#xD;
        cognitive impairment would limit the study population significantly, and potentially&#xD;
        compromise the generalizability of results from this observational study. In cases where&#xD;
        cognitive function precludes informed consent we will seek consent from the designated&#xD;
        legal guardian.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siddhartha Mahanty, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135.</citation>
    <PMID>21912406</PMID>
  </reference>
  <reference>
    <citation>Nash T. Edema surrounding calcified intracranial cysticerci: clinical manifestations, natural history, and treatment. Pathog Glob Health. 2012 Sep;106(5):275-9. doi: 10.1179/2047773212Y.0000000026.</citation>
    <PMID>23265551</PMID>
  </reference>
  <reference>
    <citation>Fleury A, Carrillo-Mezo R, Flisser A, Sciutto E, Corona T. Subarachnoid basal neurocysticercosis: a focus on the most severe form of the disease. Expert Rev Anti Infect Ther. 2011 Jan;9(1):123-33. doi: 10.1586/eri.10.150.</citation>
    <PMID>21171883</PMID>
  </reference>
  <verification_date>June 13, 2017</verification_date>
  <study_first_submitted>September 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seizures</keyword>
  <keyword>Cestode</keyword>
  <keyword>Hydrocephalus</keyword>
  <keyword>Taenia Solium</keyword>
  <keyword>Helminth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurocysticercosis</mesh_term>
    <mesh_term>Cysticercosis</mesh_term>
    <mesh_term>Taeniasis</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/NCT02233855
org study id: 140191
secondary id: 14-I-0191
nct id: NCT02233855
lead sponsor: 
Background:

      - Neurocysticercosis (NCC) is caused by tapeworms that infect people. NCC can lead to serious
      brain problems such as seizures, sevre headaches and difficulties with movements or sensation
      in the limbs. Researchers want to learn more about the different ways in which people in the
      United States present with this disease and how they respond to standard and newer
      treatments.

      Objective:

      - To learn about the different forms of NCC that occurs throughout North America and how
      patients with these forms respond to treatment.

      Eligibility:

      - Adults age 18 or older with NCC.

      Design:

        -  Participants will be screened with:

        -  Medical history and physical exam.

        -  A computed tomography (CT) brain scan The participant will lie still on a table that
           slides into a large donut-shaped scanner.

        -  Blood drawn through an arm vein for analysis

        -  A magnetic resonance imaging (MRI) scan of the brain and spine. They will lay flat in a
           long metal cylinder as the machine makes images of the body. During the scan,
           participants will receive a contrast agent through an IV that allows high resolution
           imaging of the brain and spine

        -  Participants will visit the clinic at 0, 1, 2, 3, 6, 12, and 24 months (7 times), and
           depending on the need for monitoring, more times. Participants will receive a schedule
           that will explain the procedures done at each visit.

        -  At these visits, participants may:

        -  Repeat the screening procedures.

        -  Be asked about their NCC symptoms and their physical and mental health.

        -  Have a urine test.

        -  Take a test of their ability to concentrate, their memory and spatial recognition.

        -  Have a lumbar puncture, if indicated by the state and severity of infection. A needle
           will be inserted through the skin and into the space between the bones in the back.
           Cerebrospinal fluid will be removed.
Neurocysticercosis (NCC) is the most common helminthic CNS infection and the main cause of
      adult-onset seizures in low-to-middle income countries. Studies have documented significant
      endemicity in Latin America, Eastern Europe, sub-Saharan Africa, India and other parts of the
      world. The prevalence of NCC in North America is rising as a result of increased migration of
      people with the disease and, occasionally, immigration of individuals with asymptomatic
      tapeworms. Despite the gains in knowledge and understanding of the epidemiology,
      pathophysiology, diagnosis, and treatment, clinical care continues to be hampered by
      unanswered fundamental questions related to optimal diagnosis, staging, treatment, and
      follow-up of patients with NCC.

      This multi-center, natural history study seeks to characterize: the frequency of the various
      forms of NCC in North American populations; the spectrum of treatment and management
      strategies across the North American Cysticercosis Consortium; and the response to therapy by
      evaluating a number of endpoints related to disease evolution and treatment, such as burden
      of disease, cognitive changes, radiographic changes, and treatment complications. This study
      will inform future research studies needed to eventually establish standardized management
      protocols for each form of this complex infection.

      Subjects will have visits at screening, baseline, 1, 2 (optional), 3, 6, 12, and 24 months.
      Evaluations will include assessment of clinical status, antigen assays, radiographic imaging,
      functional assessments, immunologic evaluations, cognitive assessments, and quality of life
      measures. Additional clinically indicated visits may be scheduled as needed. This study does
      not provide any interventional therapies but will collect data on the course of treatment.
      Diagnostic examinations, consultations and medical treatment will be determined by the study
      clinician. Any samples removed for medical indications related to NCC may be evaluated for
      research purposes.
observational model: Cohort
time perspective: Prospective
measure: The heterogeneity and complexity of the different forms of NCC will make it necessary to use different endpoints in analyzing the data collected from patients with each subtype of NCC. The endpoints listed here will be tailored and applied to th...
time frame: Throughout the course of the study
measure: To characterize the spectrum of diagnostic and treatment approaches across sites, including type and length of anthelmintic, anti-inflammatories, and anticonvulsants
time frame: Throughout the course of the study.
measure: To determine exposure risks and estimate time to clinical symptomatic disease (incubation time) for each form of NCC
time frame: Throughout the course of the study.
measure: For each form of NCC, to assess patient outcomes relative to: a) duration and type of anthelmintic therapy; b) duration and type of immunosuppressive therapy; and c) anticonvulsant therapy
time frame: Throughout the course of the study.
measure: To correlate clinical features with radiographic findings at presentation, during treatment and follow-up for each form of NCC
time frame: Throughout the course of the study.
measure: Determine proportion of patients with clinical and radiographic success 1 and 2 years after initiation of therapy. Definition of radiographic success will vary by form of NCC, but be based upon improvement followed by radiologic stability or slo...
time frame: Throughout the course of the study.
measure: To enumerate complications associated with NCC or treatment type for each form of NCC
time frame: Throughout the course of the study.
measure: To characterize and correlate the clinical features, radiographic findings, antigen presence and levels, and antibody responses for NCC with perilesional edema
time frame: Throughout the course of the study.
measure: To assess diagnostic parameters of serology and antigen detection assays in North American patients
time frame: Throughout the course of the study.
measure: To correlate antigen levels in serum and CSF with burden of disease and recurrence of disease in subjects with NCC
time frame: Throughout the course of the study.
measure: To characterize cognitive function at baseline, 6, 12, and 24 months as assessed by the Montreal Cognitive Assessment (MOCA) test
time frame: Throughout the course of the study.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Siddhartha Mahanty, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135.
PMID: 21912406
citation: Nash T. Edema surrounding calcified intracranial cysticerci: clinical manifestations, natural history, and treatment. Pathog Glob Health. 2012 Sep;106(5):275-9. doi: 10.1179/2047773212Y.0000000026.
PMID: 23265551
citation: Fleury A, Carrillo-Mezo R, Flisser A, Sciutto E, Corona T. Subarachnoid basal neurocysticercosis: a focus on the most severe form of the disease. Expert Rev Anti Infect Ther. 2011 Jan;9(1):123-33. doi: 10.1586/eri.10.150.
PMID: 21171883
responsible party type: Sponsor
mesh term: Neurocysticercosis
mesh term: Cysticercosis
mesh term: Taeniasis