<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/NCT03254680</url>
  </required_header>
  <id_info>
    <org_study_id>17-00750</org_study_id>
    <nct_id>NCT03254680</nct_id>
  </id_info>
  <brief_title>Turmeric as Treatment in Epilepsy</brief_title>
  <official_title>Turmeric as Treatment in Epilepsy</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center open-label pilot clinical trial of patients 1-70 years of age with&#xD;
      greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome,&#xD;
      Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a&#xD;
      stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers&#xD;
      will be asked to keep a seizure diary logging all clinical events during the course of the&#xD;
      study. Serum comprehensive metabolic panel, complete blood count with differential, and&#xD;
      antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2018</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of epilepsy patients enrolled in study</measure>
    <time_frame>3 months</time_frame>
    <description>feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of epilepsy seizures post epilepsy treatment with turmeric</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Epilepsy</condition>
  <condition>Dravet Syndrome</condition>
  <condition>Lennox-Gastaut Syndrome</condition>
  <condition>Tuberous Sclerosis</condition>
  <condition>Focal Seizures</condition>
  <arm_group>
    <arm_group_label>Turmeric Oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>stable dose of orally administered turmeric oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Turmeric</intervention_name>
    <description>Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.</description>
    <arm_group_label>Turmeric Oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with greater than greater than six seizures per month diagnosed with Dravet&#xD;
             Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures followed at&#xD;
             NYU CEC.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients expected to have changes to any medications or supplements during study&#xD;
             period&#xD;
&#xD;
          -  exposure to any investigational agent in the month prior to study entry&#xD;
&#xD;
          -  pregnant or breast feeding women, positive pregnancy test&#xD;
&#xD;
          -  history of non-compliance&#xD;
&#xD;
          -  known drug or alcohol dependence&#xD;
&#xD;
          -  known baseline hematologic&#xD;
&#xD;
          -  liver function&#xD;
&#xD;
          -  renal function&#xD;
&#xD;
          -  absorption&#xD;
&#xD;
          -  absorption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manisha Holmes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>April 26, 2018</last_update_submitted>
  <last_update_submitted_qc>April 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Turmeric Oil</keyword>
  <keyword>antiseizure medications</keyword>
  <keyword>ar-turmerone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberous Sclerosis</mesh_term>
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Epilepsies, Myoclonic</mesh_term>
    <mesh_term>Lennox Gastaut Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03254680
org study id: 17-00750
nct id: NCT03254680
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single center open-label pilot clinical trial of patients 1-70 years of age with
      greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome,
      Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a
      stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers
      will be asked to keep a seizure diary logging all clinical events during the course of the
      study. Serum comprehensive metabolic panel, complete blood count with differential, and
      antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3
      months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of epilepsy patients enrolled in study
time frame: 3 months
description: feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.
measure: Number of epilepsy seizures post epilepsy treatment with turmeric
time frame: 3 months
arm group label: Turmeric Oil
arm group type: Experimental
description: stable dose of orally administered turmeric oil
intervention type: Dietary Supplement
intervention name: Turmeric
description: Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.
arm group label: Turmeric Oil
criteria: 
gender: All
minimum age: 1 Year
maximum age: 70 Years
healthy volunteers: No
last name: Manisha Holmes, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tuberous Sclerosis
mesh term: Epilepsy
mesh term: Seizures
mesh term: Epilepsies, Myoclonic
mesh term: Lennox Gastaut Syndrome
mesh term: Syndrome
sharing ipd: Undecided