<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/NCT02969642</url>
  </required_header>
  <id_info>
    <org_study_id>AP 1001</org_study_id>
    <nct_id>NCT02969642</nct_id>
  </id_info>
  <brief_title>Study of Low-level Laser Therapy in the Acute Treatment of Migraine</brief_title>
  <official_title>A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The San Francisco Clinical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The San Francisco Clinical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the treatment of migraine pain using low energy laser light to quench&#xD;
      migraine signals issuing from the sphenopalatine ganglion (SPG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The&#xD;
      sham laser emits approximately 1/1000 the energy of the treatment laser.&#xD;
&#xD;
      It is presumed that pain relief from the treatment laser is achieved by exhausting the&#xD;
      release of neurotransmitters from the SPG following laser stimulation. Subjects will be&#xD;
      treated and subsequently queried at time intervals for their self-assessment of pain score&#xD;
      (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment.&#xD;
      Subjects will be further contacted 24 hours and one month post treatment. Adverse events will&#xD;
      be monitored and recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences between treatment groups in pain free rates at 2 hours post treatment.</measure>
    <time_frame>2 hours post treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Migraine Headache</condition>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham low energy laser using approximately 1/1000 th energy of treatment laser.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment laser.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Argus Migraine Treatment device</intervention_name>
    <description>treatment of Migraines targeting Sphenopalatine ganglion</description>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>low energy laser therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  aged 18 or older;&#xD;
&#xD;
          -  subject diagnosed with migraine according to The International Classification of&#xD;
             Headache Disorders- Version 3;&#xD;
&#xD;
          -  1-20 headache days per month;&#xD;
&#xD;
          -  history of at least moderate pain if migraine left untreated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  headache on greater than 25 days/month on average for preceding 3 months;&#xD;
&#xD;
          -  headache on greater than 25 days in present month;&#xD;
&#xD;
          -  headache attributed to: head or neck trauma, cluster headache, specific migraine&#xD;
             variants such as basilar artery, ophthalmoplegic, hemiplegic, etc;&#xD;
&#xD;
          -  women of child bearing age not using acceptable method of contraception;&#xD;
&#xD;
          -  pregnant or nursing women;&#xD;
&#xD;
          -  history of malignancy of any organ&#xD;
&#xD;
          -  uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics,&#xD;
             analgesic or alcohol abuse;&#xD;
&#xD;
          -  light sensitivity;&#xD;
&#xD;
          -  retinal disease;&#xD;
&#xD;
          -  intranasal pathology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Francisco Clinical Research Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jerome Goldstein, MD</last_name>
      <phone>415-673-4600</phone>
      <email>JGoldstein@sfcrc.org</email>
    </contact>
    <investigator>
      <last_name>Jerome Goldstein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</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>
    <mesh_term>Headache</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/NCT02969642
org study id: AP 1001
nct id: NCT02969642
lead sponsor: 
has dmc: No
This study evaluates the treatment of migraine pain using low energy laser light to quench
      migraine signals issuing from the sphenopalatine ganglion (SPG).
This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The
      sham laser emits approximately 1/1000 the energy of the treatment laser.

      It is presumed that pain relief from the treatment laser is achieved by exhausting the
      release of neurotransmitters from the SPG following laser stimulation. Subjects will be
      treated and subsequently queried at time intervals for their self-assessment of pain score
      (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment.
      Subjects will be further contacted 24 hours and one month post treatment. Adverse events will
      be monitored and recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Differences between treatment groups in pain free rates at 2 hours post treatment.
time frame: 2 hours post treatment
arm group label: Sham
arm group type: Sham Comparator
description: Sham low energy laser using approximately 1/1000 th energy of treatment laser.
arm group label: Treatment
arm group type: Active Comparator
description: Treatment laser.
intervention type: Device
intervention name: Argus Migraine Treatment device
description: treatment of Migraines targeting Sphenopalatine ganglion
arm group label: Sham
arm group label: Treatment
other name: low energy laser therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache
sharing ipd: No