<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/NCT02243644</url>
  </required_header>
  <id_info>
    <org_study_id>IESC/T-320/02.08.2013</org_study_id>
    <nct_id>NCT02243644</nct_id>
  </id_info>
  <brief_title>Effects of 2 Different Duration of Albendazole Therapy in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT</brief_title>
  <official_title>A Clinical Trial to Study the Effects of Two Different Duration of Same Drug Albendazole in Patients With Neurocysticercosis in Brain ≤ 5 Lesions on CT Scan Head at the End of 6 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>All India Institute of Medical Sciences, New Delhi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing the effect of two different duration of same drug albendazole in patients with&#xD;
      Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial will be comparing the effectiveness of short and long duration of albendazole ie 7&#xD;
      and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete&#xD;
      resolution or calcification of cyst on CT head at the end of 6 months after starting&#xD;
      albendazole&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole</measure>
    <time_frame>1 year</time_frame>
    <description>A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load &lt; 5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of seizure occurrence</measure>
    <time_frame>1 year</time_frame>
    <description>A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load &lt; 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of occurrence of other symptoms attributable to Neurocysticercosis</measure>
    <time_frame>1 year</time_frame>
    <description>A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load &lt; 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of occurrence of side effects of albendazole</measure>
    <time_frame>1 year</time_frame>
    <description>A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load &lt; 5</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Neurocysticercosis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>7 days of albendazole 15 mg/kg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>28 days of albendazole 15 mg/kg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>7 days of albendazole 15 mg/kg/day</intervention_name>
    <description>group A will receive 7 days of oral albendazole 15 mg/kg/day</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>Zentel</other_name>
    <other_name>Bandy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>28 days of albendazole 15 mg/kg/day</intervention_name>
    <description>group B will receive 28 days of oral albendazole 15 mg/kg/day</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Zentel</other_name>
    <other_name>Bandy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 2-18 years.&#xD;
&#xD;
          -  Number of parenchymal lesions: upto 5*&#xD;
&#xD;
          -  Stages of cysticerci at which albendazole treatment is effective&#xD;
&#xD;
          -  Vesicular stage&#xD;
&#xD;
          -  Colloid vesicular stage&#xD;
&#xD;
          -  Granular nodular stage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cysticercotic encephalitis&#xD;
&#xD;
          -  Calcified cyst&#xD;
&#xD;
          -  Hydrocephalus&#xD;
&#xD;
          -  Intraventricular cyst&#xD;
&#xD;
          -  Subarachnoid cyst&#xD;
&#xD;
          -  Ophthalmic Cysticercosis&#xD;
&#xD;
          -  No of cysts &gt;5&#xD;
&#xD;
          -  Known allergy to benzimidazole class of compound which includes anaphylaxis,&#xD;
             hypotension, severe skin reactions .&#xD;
&#xD;
          -  Features of raised ICT (papilloedema, hyperventilation, hypertension, tonic posturing,&#xD;
             B/L 6th nerve palsy, features of midline shift on CT/MRI)&#xD;
&#xD;
          -  Critically sick (respiratory failure, cardiovascular instability)&#xD;
&#xD;
          -  Already received albendazole or praziquantel or steroid therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheffali Gulati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AIIMS, New Delhi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>sheffali Gulati</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>May 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>December 31, 2015</last_update_submitted>
  <last_update_submitted_qc>December 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
    <investigator_full_name>Sheffali Gulati</investigator_full_name>
    <investigator_title>Additional professor, dept of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>parenchymal neurocysticercosis upto five lesions</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albendazole</mesh_term>
  </intervention_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/NCT02243644
org study id: IESC/T-320/02.08.2013
nct id: NCT02243644
lead sponsor: 
has dmc: Yes
Comparing the effect of two different duration of same drug albendazole in patients with
      Neurocysticercosis less than or equal to 5 lesions on CT head at the end of 6 months.
The trial will be comparing the effectiveness of short and long duration of albendazole ie 7
      and 28 days therapy in patients with parenchymal neurocysticercosis in terms of complete
      resolution or calcification of cyst on CT head at the end of 6 months after starting
      albendazole
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of cyst resolved/ calcified completely after therapy. Resolution or calcification of cyst assessed on CT head at the end of 6 months after starting albendazole
time frame: 1 year
description: A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
measure: Frequency of seizure occurrence
time frame: 1 year
description: A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
measure: Frequency of occurrence of other symptoms attributable to Neurocysticercosis
time frame: 1 year
description: A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
measure: Frequency of occurrence of side effects of albendazole
time frame: 1 year
description: A randomized open labeled control clinical trial to compare the radiological outcome of 7 days versus 28 days albendazole therapy along with steroid in patients with parenchymal neurocysticercosis with lesion load < 5
arm group label: Group A
arm group type: Active Comparator
description: 7 days of albendazole 15 mg/kg/day
arm group label: Group B
arm group type: Active Comparator
description: 28 days of albendazole 15 mg/kg/day
intervention type: Drug
intervention name: 7 days of albendazole 15 mg/kg/day
description: group A will receive 7 days of oral albendazole 15 mg/kg/day
arm group label: Group A
other name: Zentel
other name: Bandy
intervention type: Drug
intervention name: 28 days of albendazole 15 mg/kg/day
description: group B will receive 28 days of oral albendazole 15 mg/kg/day
arm group label: Group B
other name: Zentel
other name: Bandy
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Sheffali Gulati, MD
role: Principal Investigator
affiliation: AIIMS, New Delhi
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: All India Institute of Medical Sciences, New Delhi
investigator full name: Sheffali Gulati
investigator title: Additional professor, dept of Pediatrics
mesh term: Neurocysticercosis
mesh term: Cysticercosis
mesh term: Taeniasis
mesh term: Albendazole