<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/NCT02259075</url>
  </required_header>
  <id_info>
    <org_study_id>BTACM2014</org_study_id>
    <secondary_id>2014-001852-43</secondary_id>
    <nct_id>NCT02259075</nct_id>
  </id_info>
  <brief_title>Botox Injection in Treatment of Chronic Migraine</brief_title>
  <official_title>Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as&#xD;
      headaches for at least 15 days per month, of which 8 days have typical migraine features. In&#xD;
      many cases, oral drug treatment has little effect.&#xD;
&#xD;
      The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved&#xD;
      in several primary headaches, including migraine, by facilitating release of inflammatory&#xD;
      substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of&#xD;
      acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.&#xD;
&#xD;
      The purpose of the present study is to evaluate a new technique with injection of BTA using&#xD;
      an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The&#xD;
      goal is to relieve the migraine symptoms and develop an alternate treatment for cases where&#xD;
      oral drug treatments fail.&#xD;
&#xD;
      The main objective of the project is to determine the safety of this method of BTA injection&#xD;
      in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives&#xD;
      are to measure changes in headache attack parameters with this novel method.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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 adverse events and number of participants with adverse events</measure>
    <time_frame>For the follow-up period of 3 months</time_frame>
    <description>Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of headache days with moderate or severe intensity</measure>
    <time_frame>5-8 weeks</time_frame>
    <description>measured from week 5 to week 8, in total during 4 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of reponders</measure>
    <time_frame>12 weeks</time_frame>
    <description>response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days with moderate or severe headache per 4 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>week 1-4, week 5-8, week 9-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days without headache per 4 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>week 1-4, week 5-8, week 9-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hours with headache of moderate or severe headache per 4 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>week 1-4, week 5-8, week 9-12</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Migraine Disorders</condition>
  <arm_group>
    <arm_group_label>Botulinum Toxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin Type A</intervention_name>
    <arm_group_label>Botulinum Toxin</arm_group_label>
    <other_name>Botox</other_name>
    <other_name>BTA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
          -  Chronic migraine with or without aura defined in International Classification of&#xD;
             Headache Disorders (ICHD)-3 criteria&#xD;
&#xD;
          -  Failed at least 3 oral migraine prophylactic treatments&#xD;
&#xD;
          -  Duration of migraine at least 1 year before inclusion&#xD;
&#xD;
          -  Start of migraine before participant turned 50 years&#xD;
&#xD;
          -  Participant can make a distinction between migraine and other types of headache&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the criteria for medication-overuse headache (MOH) is fulfilled&#xD;
&#xD;
          -  Heart or lung disease&#xD;
&#xD;
          -  Any kind of systematic or local disease or illness that may significantly increase the&#xD;
             risk of complications for the procedure related to injection&#xD;
&#xD;
          -  Psychiatric illness that hinders participation in the study&#xD;
&#xD;
          -  Known pregnancy or breast feeding&#xD;
&#xD;
          -  Inadequate use of contraceptives&#xD;
&#xD;
          -  Overuse or abuse of opioids&#xD;
&#xD;
          -  Abuse of medications, narcotics or alcohol&#xD;
&#xD;
          -  Anomalies which hinder or impede the used method of injection&#xD;
&#xD;
          -  Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain&#xD;
             or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other&#xD;
             related medication&#xD;
&#xD;
          -  Treatment with medication that can interact with botulinum toxin type A&#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>Erling A Tronvik, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neuroscience, Norwegian University of Science and Technology</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Bratbak DF, Nordgard S, Stovner LJ, Linde M, Dodick DW, Aschehoug I, Folvik M, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine. Cephalalgia. 2017 Apr;37(4):356-364. doi: 10.1177/0333102416648328. Epub 2016 May 6.</citation>
    <PMID>27154997</PMID>
  </results_reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>May 20, 2016</last_update_submitted>
  <last_update_submitted_qc>May 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine with aura</keyword>
  <keyword>Migraine without aura</keyword>
  <keyword>Headache disorders</keyword>
  <keyword>Botulinum Toxin Type A</keyword>
  <keyword>Sphenopalatine Ganglion Block</keyword>
  <keyword>Autonomic Nerve Block</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>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02259075
org study id: BTACM2014
secondary id: 2014-001852-43
nct id: NCT02259075
lead sponsor: 
collaborator: 
has dmc: Yes
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as
      headaches for at least 15 days per month, of which 8 days have typical migraine features. In
      many cases, oral drug treatment has little effect.

      The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved
      in several primary headaches, including migraine, by facilitating release of inflammatory
      substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of
      acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.

      The purpose of the present study is to evaluate a new technique with injection of BTA using
      an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The
      goal is to relieve the migraine symptoms and develop an alternate treatment for cases where
      oral drug treatments fail.

      The main objective of the project is to determine the safety of this method of BTA injection
      in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives
      are to measure changes in headache attack parameters with this novel method.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of adverse events and number of participants with adverse events
time frame: For the follow-up period of 3 months
description: Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.
measure: Number of headache days with moderate or severe intensity
time frame: 5-8 weeks
description: measured from week 5 to week 8, in total during 4 weeks
measure: Number of reponders
time frame: 12 weeks
description: response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)
measure: Days with moderate or severe headache per 4 weeks
time frame: 12 weeks
description: week 1-4, week 5-8, week 9-12
measure: Days without headache per 4 weeks
time frame: 12 weeks
description: week 1-4, week 5-8, week 9-12
measure: Hours with headache of moderate or severe headache per 4 weeks
time frame: 12 weeks
description: week 1-4, week 5-8, week 9-12
arm group label: Botulinum Toxin
arm group type: Experimental
description: The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU.
intervention type: Drug
intervention name: Botulinum Toxin Type A
arm group label: Botulinum Toxin
other name: Botox
other name: BTA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Erling A Tronvik, PhD, MD
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
citation: Bratbak DF, Nordgard S, Stovner LJ, Linde M, Dodick DW, Aschehoug I, Folvik M, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine. Cephalalgia. 2017 Apr;37(4):356-364. doi: 10.1177/0333102416648328. Epub 2016 May 6.
PMID: 27154997
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA