<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/NCT03834337</url>
  </required_header>
  <id_info>
    <org_study_id>TOPANA</org_study_id>
    <nct_id>NCT03834337</nct_id>
  </id_info>
  <brief_title>Treatment of Patients With Active Neurocysticercosis in Eastern Africa</brief_title>
  <acronym>TOPANA</acronym>
  <official_title>Characteristics of Patients With Symptomatic Active Neurocysticercosis and Effect of Treatment on Symptoms, Lesions and Quality of Life in Resource-poor Rural Areas of Eastern Africa - TOPANA, a Multi-centre Prospective Cohort Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Medical Research, Tanzania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Zambia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sokoine University of Agriculture</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technical University of Munich</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>
      This multi-centre prospective cohort study of symptomatic patients with active&#xD;
      neurocysticercosis (NCC) aims to identify factors related to treatment success of&#xD;
      anthelmintic therapy.&#xD;
&#xD;
      Neurological symptom/sign and cyst resolution, quality of life, accuracy and performance of&#xD;
      serological T. solium diagnostics and NCC-specific immunological parameter will be followed&#xD;
      up at multiple time points in the study. The final assessment will be done six months after&#xD;
      the end of anthelmintic treatment. This study aims to guide treatment of NCC in sub-Saharan&#xD;
      Africa by identifying factors that are associated with treatment outcomes.&#xD;
&#xD;
      The factors that cause some people to fail complete resolution of all cysts and/or&#xD;
      symptoms/signs are unknown.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>Symptom/sign frequency</measure>
    <time_frame>Change of symptom/sign frequency from before treatment to six months after treatment termination</time_frame>
    <description>The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resolution of lesions</measure>
    <time_frame>Change in number of active cysts from before treatment to six months after treatment termination</time_frame>
    <description>The number of active cysts identified by CT scan after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in presence of T.solium-specific antigen</measure>
    <time_frame>Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination</time_frame>
    <description>Change in presence of T.solium-specific antigen in the blood of patients with active neurocysticercosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire</measure>
    <time_frame>Change in quality of life from before treatment to six months after treatment termination</time_frame>
    <description>The change in participants' self-reported quality of life from before to after treatment, as measured by the WHOQOL-Bref questionnaire (in all participants) [World Health Organization Quality of Life questionnaire; consisting of 26 items].&#xD;
Quality of life is assessed by four domains - physical health, psychological, social relationships and environment. In each domain a score of 0 to 100 can be achieved. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Domains are not summarised to an overall score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life (epileptic patients)</measure>
    <time_frame>Change in quality of life from before treatment to six months after treatment termination</time_frame>
    <description>The change in participants' self-reported quality of life from before to after treatment, as measured by the QOLIE-31 questionnaire [Quality of life in epilepsy - 31 items].&#xD;
The score consists of 7 domains which all are range from 0 to 100%. Those domains are: seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive, medication effects, social function. The seven domains are then summarized to an overall score by applying weights to each category. The overall score ranges from 0 to 100% with 100% being best possible quality of life.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Neurocysticercosis</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and stool samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with active, symptomatic neurocysticercosis in rural areas in Tanzania&#xD;
        and Zambia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients will be included who&#xD;
&#xD;
          -  Meet the definitions of active NCC&#xD;
&#xD;
          -  Have epilepsy, epileptic seizures or chronic/severe progressive headaches&#xD;
&#xD;
          -  Are physically and mentally fit enough for treatment&#xD;
&#xD;
          -  Are willing to be hospitalized and to receive the standard treatment for NCC&#xD;
&#xD;
          -  Are willing to participate a follow-up for six months&#xD;
&#xD;
          -  Are willing and able to consent to this study, with consent recorded on a signed&#xD;
             consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Potential participants who will not meet the above inclusion criteria will be&#xD;
             excluded.&#xD;
&#xD;
          -  Women who are pregnant will not be included, but re-evaluated for inclusion into the&#xD;
             study after they have given birth.&#xD;
&#xD;
          -  Potential participants who are currently taking or have taken albendazole,&#xD;
             praziquantel, or a corticosteroid within the past 12 months will be excluded.&#xD;
&#xD;
          -  People with uncontrolled hypertension and/or diabetes will be excluded from the study&#xD;
             but will be re-evaluated for inclusion once their hypertension and/or diabetes have&#xD;
             been treated.&#xD;
&#xD;
          -  People with chronic consuming illness such as cancer and those with mental handicap&#xD;
             severe enough to not allow them to follow the study instructions or reliably take&#xD;
             their medication will be excluded.&#xD;
&#xD;
          -  Children aged &lt;10 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andrea S Winkler, MD, PhD</last_name>
    <phone>+49894140</phone>
    <phone_ext>9210</phone_ext>
    <email>andrea.winkler@tum.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dominik Stelzle, MD, MPH</last_name>
    <phone>+49894140</phone>
    <phone_ext>6096</phone_ext>
    <email>dominik.stelzle@tum.de</email>
  </overall_contact_backup>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03834337
org study id: TOPANA
nct id: NCT03834337
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multi-centre prospective cohort study of symptomatic patients with active
      neurocysticercosis (NCC) aims to identify factors related to treatment success of
      anthelmintic therapy.

      Neurological symptom/sign and cyst resolution, quality of life, accuracy and performance of
      serological T. solium diagnostics and NCC-specific immunological parameter will be followed
      up at multiple time points in the study. The final assessment will be done six months after
      the end of anthelmintic treatment. This study aims to guide treatment of NCC in sub-Saharan
      Africa by identifying factors that are associated with treatment outcomes.

      The factors that cause some people to fail complete resolution of all cysts and/or
      symptoms/signs are unknown.
observational model: Cohort
time perspective: Prospective
measure: Symptom/sign frequency
time frame: Change of symptom/sign frequency from before treatment to six months after treatment termination
description: The percentage of participants who exhibit a neurological symptom/sign of NCC: chronic/severe progressive headache or epileptic seizures.
measure: Resolution of lesions
time frame: Change in number of active cysts from before treatment to six months after treatment termination
description: The number of active cysts identified by CT scan after treatment
measure: Change in presence of T.solium-specific antigen
time frame: Change in presence of T.solium-specific antigen from before treatment to six months after treatment termination
description: Change in presence of T.solium-specific antigen in the blood of patients with active neurocysticercosis
measure: Health-related Quality of Life (all patients): WHOQOL-Bref questionnaire
time frame: Change in quality of life from before treatment to six months after treatment termination
description: The change in participants' self-reported quality of life from before to after treatment, as measured by the WHOQOL-Bref questionnaire (in all participants) [World Health Organization Quality of Life questionnaire; consisting of 26 items].
Quality of life is assessed by four domains - physical health, psychological, social relationships and environment. In each domain a score of 0 to 100 can be achieved. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Domains are not summarised to an overall score.
measure: Health-related Quality of Life (epileptic patients)
time frame: Change in quality of life from before treatment to six months after treatment termination
description: The change in participants' self-reported quality of life from before to after treatment, as measured by the QOLIE-31 questionnaire [Quality of life in epilepsy - 31 items].
The score consists of 7 domains which all are range from 0 to 100%. Those domains are: seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive, medication effects, social function. The seven domains are then summarized to an overall score by applying weights to each category. The overall score ranges from 0 to 100% with 100% being best possible quality of life.
Blood and stool samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea S Winkler, MD, PhD
phone: +49894140
phone ext: 9210
email: andrea.winkler@tum.de
last name: Dominik Stelzle, MD, MPH
phone: +49894140
phone ext: 6096
email: dominik.stelzle@tum.de
responsible party type: Sponsor
mesh term: Neurocysticercosis
mesh term: Cysticercosis
mesh term: Taeniasis