<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/NCT04463875</url>
  </required_header>
  <id_info>
    <org_study_id>Corfu HC</org_study_id>
    <nct_id>NCT04463875</nct_id>
  </id_info>
  <brief_title>Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis</brief_title>
  <official_title>Real World, Open Label Prospective Experience of Supplementation With a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corfu Headache Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corfu Headache Clinic</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>
      To investigate efficacy and safety of a supplementation with a fixed combination of&#xD;
      magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in&#xD;
      episodic migraine prevention, by an observational, prospective real-world study in 113 Greek&#xD;
      patients with episodic migraine that were prospectively followed-up for three months. The&#xD;
      primary endpoint was the change in monthly migraine days between baseline period (BL)and the&#xD;
      third month of treatment (T3).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate efficacy and safety of a supplementation with a fixed combination of&#xD;
      magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in&#xD;
      episodic migraine prevention.&#xD;
&#xD;
      An observational, prospective real-world study. After a one-month baseline period, Vivinor®&#xD;
      was introduced in 113 Greek patients with episodic migraine that were prospectively&#xD;
      followed-up for three months. The primary endpoint was the change in monthly migraine days&#xD;
      between baseline period (BL)and the third month of treatment (T3). Secondary endpoints&#xD;
      included changes in mean intensity of migraine and in days with use of acute migraine&#xD;
      medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS),&#xD;
      Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL&#xD;
      (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression&#xD;
      Scale) were also evaluated. Those with ≥50% reduction in monthly migraine days during T3&#xD;
      compared to BL were considered Vivinor®-responders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in monthly migraine days</measure>
    <time_frame>3 months</time_frame>
    <description>Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean intensity of migraine</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days with use of acute migraine medications</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in days with use of acute migraine medications between baseline period (BL) and the third month of treatment (T3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Migraine Disability Assessment questionnaire (MIDAS)</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Impact Test-6 (HIT-6)</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in Headache Impact Test-6 (HIT-6) during T3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Migraine Therapy Assessment questionnaire (MTAQ)</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Migraine responders</measure>
    <time_frame>3 months</time_frame>
    <description>Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.</description>
  </other_outcome>
  <enrollment type="Actual">113</enrollment>
  <condition>Migraine</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10</intervention_name>
    <description>Supplementation per os</description>
    <other_name>Vivinor</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients with a documented history of episodic migraine with or without aura for more&#xD;
        than the 12 months prior to screening, according to the criteria of the International&#xD;
        Classification of Headaches Disorders-III (IHS, 2013)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  established diagnosis of episodic migraine with or without aura for more than one year&#xD;
             prior to study entry&#xD;
&#xD;
          -  evidence of 4-14 migraine days per month during the last trimester prior to screening&#xD;
&#xD;
          -  participants may had been either treatment- naive or not suitable for or had failed&#xD;
             previous migraine pharmacological prophylactic treatments&#xD;
&#xD;
          -  were able to fully understand protocol and study information provided by the&#xD;
             investigators.&#xD;
&#xD;
          -  enrolled patients should take no other preventive treatment or use any other migraine&#xD;
             prophylactic method during the three months before entering the study and throughout&#xD;
             the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  older than 50 years of age at migraine onset&#xD;
&#xD;
          -  evidence of MOH&#xD;
&#xD;
          -  pregnant or nursing females&#xD;
&#xD;
          -  history of tension-type, cluster or hemiplegic headache&#xD;
&#xD;
          -  history of severe anaphylactic reactions to any of the intervention's ingredients&#xD;
&#xD;
          -  evidence of severe systemic diseases&#xD;
&#xD;
          -  history or evidence of major psychiatric disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michail Michail, MD, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mediterraneo Hospital, Glyfada, Greece</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corfu HC</name>
      <address>
        <city>Corfu</city>
        <zip>49100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Holland S, Silberstein SD, Freitag F, Dodick DW, Argoff C, Ashman E; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012 Apr 24;78(17):1346-53. doi: 10.1212/WNL.0b013e3182535d0c.</citation>
    <PMID>22529203</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corfu Headache Clinic</investigator_affiliation>
    <investigator_full_name>KONSTANTINOS SPINGOS</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>episodic migraine</keyword>
  <keyword>supplement</keyword>
  <keyword>Vivinor</keyword>
  <keyword>magnesium</keyword>
  <keyword>vitamin B2</keyword>
  <keyword>andrographis paniculata</keyword>
  <keyword>coenzyme Q10</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coenzyme Q10</mesh_term>
    <mesh_term>Riboflavin</mesh_term>
    <mesh_term>Ubiquinone</mesh_term>
    <mesh_term>Andrographolide</mesh_term>
  </intervention_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/NCT04463875
org study id: Corfu HC
nct id: NCT04463875
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate efficacy and safety of a supplementation with a fixed combination of
      magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in
      episodic migraine prevention, by an observational, prospective real-world study in 113 Greek
      patients with episodic migraine that were prospectively followed-up for three months. The
      primary endpoint was the change in monthly migraine days between baseline period (BL)and the
      third month of treatment (T3).
To investigate efficacy and safety of a supplementation with a fixed combination of
      magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in
      episodic migraine prevention.

      An observational, prospective real-world study. After a one-month baseline period, Vivinor®
      was introduced in 113 Greek patients with episodic migraine that were prospectively
      followed-up for three months. The primary endpoint was the change in monthly migraine days
      between baseline period (BL)and the third month of treatment (T3). Secondary endpoints
      included changes in mean intensity of migraine and in days with use of acute migraine
      medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS),
      Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL
      (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression
      Scale) were also evaluated. Those with ≥50% reduction in monthly migraine days during T3
      compared to BL were considered Vivinor®-responders.
observational model: Case-Only
time perspective: Prospective
measure: Change in monthly migraine days
time frame: 3 months
description: Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3)
measure: Mean intensity of migraine
time frame: 3 months
description: Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3)
measure: days with use of acute migraine medications
time frame: 3 months
description: Changes in days with use of acute migraine medications between baseline period (BL) and the third month of treatment (T3)
measure: Migraine Disability Assessment questionnaire (MIDAS)
time frame: 3 months
description: Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3
measure: Headache Impact Test-6 (HIT-6)
time frame: 3 months
description: Changes in Headache Impact Test-6 (HIT-6) during T3
measure: Migraine Therapy Assessment questionnaire (MTAQ)
time frame: 3 months
description: Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3
measure: Migraine responders
time frame: 3 months
description: Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.
intervention type: Dietary Supplement
intervention name: magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10
description: Supplementation per os
other name: Vivinor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michail Michail, MD, MSc, PhD
role: Principal Investigator
affiliation: Mediterraneo Hospital, Glyfada, Greece
facility: 
country: Greece
citation: Holland S, Silberstein SD, Freitag F, Dodick DW, Argoff C, Ashman E; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012 Apr 24;78(17):1346-53. doi: 10.1212/WNL.0b013e3182535d0c.
PMID: 22529203
responsible party type: Principal Investigator
investigator affiliation: Corfu Headache Clinic
investigator full name: KONSTANTINOS SPINGOS
investigator title: Dr.
mesh term: Migraine Disorders
mesh term: Coenzyme Q10
mesh term: Riboflavin
mesh term: Ubiquinone
mesh term: Andrographolide
sharing ipd: No