<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/NCT01687101</url>
  </required_header>
  <id_info>
    <org_study_id>SDS/STPAIN/01</org_study_id>
    <nct_id>NCT01687101</nct_id>
  </id_info>
  <brief_title>STOPAIN in the Treatment of a Single Migraine Attack</brief_title>
  <official_title>A Study to Evaluate the Efficacy and Tolerability of STOPAIN in the Treatment of a Single Migraine Attack</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with&#xD;
      or without aura. STOPAIN is an over-the-counter product that is used for the temporary relief&#xD;
      of minor aches and pains of muscles and joints associated with simple backache, arthritis,&#xD;
      strains, bruises and sprains. We plan to have subjects apply the product during a single&#xD;
      migraine attack to see if it will alleviate the headache pain and associated symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, 2 visit, pilot study of 25 subjects with a diagnosis of episodic&#xD;
      migraine with or without aura according to the International Classification of Headache&#xD;
      Disorders (2nd Edition-2004).&#xD;
&#xD;
      Subjects will be screened at Visit 1 after being properly consented for participation in the&#xD;
      study. Screening procedures will include assessment of the medical history, headache history,&#xD;
      current medications, vital signs, height and weight measurements and a urine pregnancy test&#xD;
      for women of childbearing potential. Investigators will determine the eligibility of study&#xD;
      subjects. Subjects will be instructed on how and when to apply the topical gel to treat a&#xD;
      migraine attack. In addition, subjects will be instructed how to complete the take home&#xD;
      diary. The study medication will be used at home to treat a single migraine attack.&#xD;
&#xD;
      At the time of at-home treatment the subject will apply the study medication. The gel will be&#xD;
      applied to the area below and abutting the back base of the skull to base of neck and span&#xD;
      from behind and between both ears. The quantity shall be two pumps from the metered dosing&#xD;
      bottle. The best way to apply is to pump once onto the fingertips and apply the gel to&#xD;
      one-half of the application area and pump again onto the fingertips and apply the gel to the&#xD;
      other half of the application area. Massage in for 5 to 10 seconds to make sure there is&#xD;
      reasonably uniform coverage. (Do not cover with cloth or bandage or lie down on a pillow&#xD;
      until the gel has completely dried - about 10 minutes or so.) Do not get any of the gel into&#xD;
      the eyes or onto mucus membranes. The gel is not toxic but will cause a burning sensation to&#xD;
      eyes or mucus membranes. Wash hands with soap and warm water after application. The gel will&#xD;
      give rise to a cooling sensation and to it may feel like a mild to moderate stinging or&#xD;
      burning sensation. That is normal. Anything more than a mild to moderate stinging or burning&#xD;
      sensation is not expected and should be noted in diary. If there has been no reduction in&#xD;
      symptoms after 30 minutes repeat the application. If there is no relief after 2 hours the&#xD;
      subject may use other rescue medication.&#xD;
&#xD;
      Completed subject diaries will provide data on headache severity and the presence or absence&#xD;
      of nausea, vomiting, photophobia and phonophobia. Time of resolution of both the headache and&#xD;
      accompanying symptoms will be collected. The subjects will record migraine pain severity and&#xD;
      the presence or absence of associated symptoms at 30, 60, 90 minutes and 2, 4, and 24 hours&#xD;
      after the administration of study drug.&#xD;
&#xD;
      Subjects will be asked to treat a single migraine attack within 8 weeks of Visit 1. After&#xD;
      treating the attack and completing the diary, they will be asked to return to Jefferson&#xD;
      Headache Center for a final visit (Visit 2) or to return the diary and other study supplies&#xD;
      by mail. Shipping materials will be provided to each participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Efficacy of STOPAIN in the Acute Treatment of Migraine</measure>
    <time_frame>2 hours after the time of gel application</time_frame>
    <description>To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to &quot;no pain&quot;) at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Migraine</condition>
  <condition>Headache</condition>
  <arm_group>
    <arm_group_label>STOPAIN topical gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>STOPAIN topical gel</intervention_name>
    <description>STOPAIN topical gel is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.</description>
    <arm_group_label>STOPAIN topical gel</arm_group_label>
    <other_name>Topical menthol 6% gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects between the ages of 18 and 65, inclusive&#xD;
&#xD;
          -  Subjects diagnosed with episodic migraine, with or without aura according to IHS&#xD;
             criteria for at least one year prior to screening&#xD;
&#xD;
          -  Subjects who experience between 1 and 10 migraine attacks (inclusive) per month&#xD;
             (during the previous 6 months) with no more than 15 days of headache per month.&#xD;
&#xD;
          -  Subject is using or agrees to use for the duration of participation a medically&#xD;
             acceptable form of contraception (as determined by investigator), if female of&#xD;
             child-bearing potential&#xD;
&#xD;
          -  Subjects who are able to understand and comply with all study procedures.&#xD;
&#xD;
          -  Subject provides written informed consent prior to any screening procedures being&#xD;
             conducted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and/or lactating women&#xD;
&#xD;
          -  Subjects who, in the investigator's opinion, have a history or have evidence of a&#xD;
             medical or psychiatric condition that would expose them to an increased risk of a&#xD;
             significant adverse event or would interfere with the assessments of efficacy and&#xD;
             tolerability during this trial&#xD;
&#xD;
          -  Subjects who have participated in an investigational drug trial in the 30 days prior&#xD;
             to the screening visit&#xD;
&#xD;
          -  Subjects who currently have or have had a history of basilar or hemiplegic migraine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen D Silberstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>February 19, 2015</results_first_submitted>
  <results_first_submitted_qc>April 7, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 27, 2015</results_first_posted>
  <last_update_submitted>May 5, 2017</last_update_submitted>
  <last_update_submitted_qc>May 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute migraine</keyword>
  <keyword>acute migraine treatment</keyword>
  <keyword>topical treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menthol</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>STOPAIN Topical Gel</title>
          <description>STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>STOPAIN Topical Gel</title>
          <description>STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of STOPAIN in the Acute Treatment of Migraine</title>
        <description>To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to &quot;no pain&quot;) at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain).</description>
        <time_frame>2 hours after the time of gel application</time_frame>
        <group_list>
          <group group_id="O1">
            <title>STOPAIN Topical Gel</title>
            <description>STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of STOPAIN in the Acute Treatment of Migraine</title>
          <description>To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to &quot;no pain&quot;) at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.92" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours after application of topical gel.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>STOPAIN Topical Gel</title>
          <description>STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Stinging</sub_title>
                <description>Stinging at application site resolved without treatment. Duration of 15 minutes.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Burning sensation.</sub_title>
                <description>Burning sensation on both hands after applying gel. Duration 20 minutes; severity was mild. Resoved without treatment.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Stephen D Silberstein, MD</name_or_title>
      <organization>Thomas Jefferson University, Jefferson Headache Center</organization>
      <phone>215-955-2243</phone>
      <email>bruce.smith@jefferson.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01687101
org study id: SDS/STPAIN/01
nct id: NCT01687101
lead sponsor: 
has dmc: No
This is an open label pilot study of 25 subjects with a diagnosis of episodic migraine with
      or without aura. STOPAIN is an over-the-counter product that is used for the temporary relief
      of minor aches and pains of muscles and joints associated with simple backache, arthritis,
      strains, bruises and sprains. We plan to have subjects apply the product during a single
      migraine attack to see if it will alleviate the headache pain and associated symptoms.
This is an open label, 2 visit, pilot study of 25 subjects with a diagnosis of episodic
      migraine with or without aura according to the International Classification of Headache
      Disorders (2nd Edition-2004).

      Subjects will be screened at Visit 1 after being properly consented for participation in the
      study. Screening procedures will include assessment of the medical history, headache history,
      current medications, vital signs, height and weight measurements and a urine pregnancy test
      for women of childbearing potential. Investigators will determine the eligibility of study
      subjects. Subjects will be instructed on how and when to apply the topical gel to treat a
      migraine attack. In addition, subjects will be instructed how to complete the take home
      diary. The study medication will be used at home to treat a single migraine attack.

      At the time of at-home treatment the subject will apply the study medication. The gel will be
      applied to the area below and abutting the back base of the skull to base of neck and span
      from behind and between both ears. The quantity shall be two pumps from the metered dosing
      bottle. The best way to apply is to pump once onto the fingertips and apply the gel to
      one-half of the application area and pump again onto the fingertips and apply the gel to the
      other half of the application area. Massage in for 5 to 10 seconds to make sure there is
      reasonably uniform coverage. (Do not cover with cloth or bandage or lie down on a pillow
      until the gel has completely dried - about 10 minutes or so.) Do not get any of the gel into
      the eyes or onto mucus membranes. The gel is not toxic but will cause a burning sensation to
      eyes or mucus membranes. Wash hands with soap and warm water after application. The gel will
      give rise to a cooling sensation and to it may feel like a mild to moderate stinging or
      burning sensation. That is normal. Anything more than a mild to moderate stinging or burning
      sensation is not expected and should be noted in diary. If there has been no reduction in
      symptoms after 30 minutes repeat the application. If there is no relief after 2 hours the
      subject may use other rescue medication.

      Completed subject diaries will provide data on headache severity and the presence or absence
      of nausea, vomiting, photophobia and phonophobia. Time of resolution of both the headache and
      accompanying symptoms will be collected. The subjects will record migraine pain severity and
      the presence or absence of associated symptoms at 30, 60, 90 minutes and 2, 4, and 24 hours
      after the administration of study drug.

      Subjects will be asked to treat a single migraine attack within 8 weeks of Visit 1. After
      treating the attack and completing the diary, they will be asked to return to Jefferson
      Headache Center for a final visit (Visit 2) or to return the diary and other study supplies
      by mail. Shipping materials will be provided to each participant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of STOPAIN in the Acute Treatment of Migraine
time frame: 2 hours after the time of gel application
description: To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to "no pain") at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain).
arm group label: STOPAIN topical gel
arm group type: Experimental
description: STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
intervention type: Drug
intervention name: STOPAIN topical gel
description: STOPAIN topical gel is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
arm group label: STOPAIN topical gel
other name: Topical menthol 6% gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stephen D Silberstein, MD
role: Principal Investigator
affiliation: Thomas Jefferson University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
mesh term: Menthol
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 