<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/NCT04437199</url>
  </required_header>
  <id_info>
    <org_study_id>AC-20-022</org_study_id>
    <nct_id>NCT04437199</nct_id>
  </id_info>
  <brief_title>Tricaprilin Phase 2 Pilot Study in Migraine</brief_title>
  <official_title>A 12-Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Participants With Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cerecin</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cerecin</source>
  <oversight_info>
    <has_dmc>Yes</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 randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of&#xD;
      tricaprilin as AC-SD-03 compared with placebo for the reduction of migraine in participants&#xD;
      with frequent migraine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2020</start_date>
  <completion_date type="Actual">February 7, 2022</completion_date>
  <primary_completion_date type="Actual">February 7, 2022</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of migraine headache days using headache diary parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the number of migraine headache days during Month 1 (ΔMDMth1) and Month 2 (ΔMDMth2) of treatment and overall, from Months 1-3</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
    <description>Number of migraine headache days using headache diary parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
    <description>Response rate defined as a reduction in number of migraine headache days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
    <description>Acute migraine medicine use during treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
    <description>Headache Impact Test (HIT-6) score. Total score range between 36-78 (higher score indicates a worse impact)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in the number of headache days (migraine and non-migraine headache) during treatment months 1, 2 and 3 (ΔHDMth1, ΔHDMth2 and ΔHDMth3)</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
    <description>Headache diary parameters</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in MIDAS score at the end of Month 1, 2 and 3</measure>
    <time_frame>4, 8, 12 weeks</time_frame>
    <description>Migraine Disability Assessment Scale (MIDAS) score. Total score range between 0-28 (higher score indicates more severe disability)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>AC-SD-03</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tricaprilin SD formulation, twice daily. Administered orally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AC-SD-03P</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo formulation, twice daily. Administered orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tricaprilin</intervention_name>
    <description>Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.&#xD;
Each dosing unit of 12.5 g of AC-SD-03 contains 5 g of the active ingredients (tricaprilin)</description>
    <arm_group_label>AC-SD-03</arm_group_label>
    <other_name>AC-SD-03</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.</description>
    <arm_group_label>AC-SD-03P</arm_group_label>
    <other_name>AC-SD-03P</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant must be 18 to 70 years of age inclusive, at the time of signing the&#xD;
             informed consent.&#xD;
&#xD;
          2. Participants who have frequent (episodic or chronic) migraine with or without aura,&#xD;
             for at least 1 year, according to the International Classification of Headache&#xD;
             Disorders version 3 beta (ICHD 3-beta), age at time of onset must be &lt;50 years.&#xD;
&#xD;
          3. Participants must have a certain number of migraine headaches days per month, as&#xD;
             confirmed by the baseline measurement period.&#xD;
&#xD;
          4. Use of one allowed migraine prophylactic is permitted if the participant has been on a&#xD;
             stable dose for at least 2 months prior to the screening.&#xD;
&#xD;
          5. Participants must have failed (no therapeutic response) 1-4 migraine prophylactic&#xD;
             treatments.&#xD;
&#xD;
          6. The participant is able to tolerate a 12.5g dose of AC-SD-03 (containing 5g of&#xD;
             tricaprilin) as per sentinel dose challenge at the Baseline Visit.&#xD;
&#xD;
          7. From Visit 2 to Visit 3 (baseline measurement period), the participant has sufficient&#xD;
             compliance (at least 80%) with daily eDiary headache entries.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In the opinion of the Investigator, has presence or history of an advanced, severe,&#xD;
             progressive, or unstable disease of any type that could interfere with efficacy and&#xD;
             safety assessments, or put the participant at risk.&#xD;
&#xD;
          2. Use of barbiturates (and/or butalbital-containing analgesics) or opioids (and/or&#xD;
             opioid-containing analgesics) for migraine acute treatment ≥ 4 days per month on&#xD;
             average and/or in the last month prior to Screening Visit.&#xD;
&#xD;
          3. Use in the last 3 months prior to Screening Visit of CGRP agents, Botox injections,&#xD;
             TENS, cranial nerve blocks, trigger-point injections, acupuncture, CBD-containing&#xD;
             products, infusion therapy.&#xD;
&#xD;
          4. Current use, or use within 3 months of Visit 2 (baseline), of Axona® or other&#xD;
             MCT-containing products (such as coconut oil). Use of MCT-containing products is not&#xD;
             allowed at any time during trial participation.&#xD;
&#xD;
          5. Current use, or use within 3 months prior to Screening, of a ketogenic diet, low-carb&#xD;
             diet, intermittent fasting (including the 5:2 diet). Ketogenic diets, low-carb diet,&#xD;
             intermittent fasting (including the 5:2 diet) are not allowed during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Cerecin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Paratus Clinical Central Coast</name>
      <address>
        <city>Kanwal</city>
        <state>New South Wales</state>
        <zip>2259</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holdsworth House</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paratus Clinical Research Western Sydney</name>
      <address>
        <city>Blacktown</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paratus Clinical Research Brisbane</name>
      <address>
        <city>Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emeritus Research</name>
      <address>
        <city>Camberwell</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paratus Clinical Research Canberra</name>
      <address>
        <city>Canberra</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Health Hospital</name>
      <address>
        <city>Heidelberg</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Health Hospital</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital</name>
      <address>
        <city>Southport</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</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>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04437199
org study id: AC-20-022
nct id: NCT04437199
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of
      tricaprilin as AC-SD-03 compared with placebo for the reduction of migraine in participants
      with frequent migraine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change from baseline in the number of migraine headache days during Month 3 (ΔMDMth3)
time frame: 12 weeks
description: Number of migraine headache days using headache diary parameters
measure: Change from baseline in the number of migraine headache days during Month 1 (ΔMDMth1) and Month 2 (ΔMDMth2) of treatment and overall, from Months 1-3
time frame: 4, 8, 12 weeks
description: Number of migraine headache days using headache diary parameters
measure: The proportion of participants with a 50% reduction from baseline in number of migraine headache days in treatment months 1, 2, and 3
time frame: 4, 8, 12 weeks
description: Response rate defined as a reduction in number of migraine headache days
measure: Change from baseline in monthly acute migraine medicine use during treatment months 1, 2 and 3
time frame: 4, 8, 12 weeks
description: Acute migraine medicine use during treatment
measure: Change from baseline Headache Impact Test (HIT-6) score at the end of Months 1, 2 and 3
time frame: 4, 8, 12 weeks
description: Headache Impact Test (HIT-6) score. Total score range between 36-78 (higher score indicates a worse impact)
measure: Change from baseline in the number of headache days (migraine and non-migraine headache) during treatment months 1, 2 and 3 (ΔHDMth1, ΔHDMth2 and ΔHDMth3)
time frame: 4, 8, 12 weeks
description: Headache diary parameters
measure: Change from baseline in MIDAS score at the end of Month 1, 2 and 3
time frame: 4, 8, 12 weeks
description: Migraine Disability Assessment Scale (MIDAS) score. Total score range between 0-28 (higher score indicates more severe disability)
arm group label: AC-SD-03
arm group type: Active Comparator
description: Tricaprilin SD formulation, twice daily. Administered orally
arm group label: AC-SD-03P
arm group type: Placebo Comparator
description: Placebo formulation, twice daily. Administered orally
intervention type: Drug
intervention name: Tricaprilin
description: Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
Each dosing unit of 12.5 g of AC-SD-03 contains 5 g of the active ingredients (tricaprilin)
arm group label: AC-SD-03
other name: AC-SD-03
intervention type: Drug
intervention name: Placebo
description: Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
arm group label: AC-SD-03P
other name: AC-SD-03P
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Cerecin
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: No