<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/NCT01677026</url>
  </required_header>
  <id_info>
    <org_study_id>CP-004</org_study_id>
    <nct_id>NCT01677026</nct_id>
  </id_info>
  <brief_title>Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache</brief_title>
  <official_title>Data Collection on the ATI Neurostimulation System: SPG Stimulation for Cluster Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Autonomic Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Autonomic Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of the Registry are to:&#xD;
&#xD;
        1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical&#xD;
           performance to a larger number of centers in the post market phase and&#xD;
&#xD;
        2. Collect additional evidence to support reimbursement and clinical acceptance and long&#xD;
           term follow up&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">April 9, 2018</completion_date>
  <primary_completion_date type="Actual">April 9, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:</measure>
    <time_frame>Through study completion</time_frame>
    <description>Implantation of ATI Neurostimulator within the pterygopalatine fossa&#xD;
Explant and lead-revision rates and reasons</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characterization of patient response to therapy, as evaluated by the following:</measure>
    <time_frame>Through study completion</time_frame>
    <description>Patient acceptance of the therapy&#xD;
Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both&#xD;
Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline&#xD;
Subject Overall Evaluation of Therapy&#xD;
Change in use of acute medications compared to Baseline&#xD;
Change in preventive medication use and work status compared to Baseline</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cluster Headache</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who meet the CE marked labeling for cluster headache for the ATI Neurostimulation&#xD;
        System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject meets CE marked labeling for cluster headache.&#xD;
&#xD;
          -  Subject's typical cluster headache bouts last a minimum of 16 weeks, in the opinion of&#xD;
             the Investigator.&#xD;
&#xD;
          -  Subject agrees to maintain current preventive headache medication regimens (no change&#xD;
             in type, frequency or dose except to manage tolerability) from Study Enrollment&#xD;
             through the completion of the Therapy Evaluation Period.&#xD;
&#xD;
          -  Subject has the ability to read, comprehend and to reliably record information as&#xD;
             required by the Protocol.&#xD;
&#xD;
          -  Subject is able to provide written informed consent prior to participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has had a change in type, dosage or frequency of taking preventive headache&#xD;
             medications &lt; one (1) month prior to Study Enrollment.&#xD;
&#xD;
          -  Per the CE marked labeling: In the opinion of the Investigator, subject has bony&#xD;
             facial deformities, inappropriate surgical anatomy or has had facial surgery in the&#xD;
             surgical area on the same side as the planned surgery that would prevent the proper&#xD;
             placement of the ATI Neurostimulator.&#xD;
&#xD;
          -  Subject has other significant pain problem that might confound the study assessments&#xD;
             in the opinion of the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arne May, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danish Headache Center</name>
      <address>
        <city>Glostrup</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berlin Charite Hospital</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Klinik und Poliklinik</name>
      <address>
        <city>Bochum</city>
        <zip>44789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Headache Center, Dept. Of Neurology, Univ. Duisburg-Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Jena Klinik f. Neurologie</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik fur Mund-, Kiefer-und Gesichtschirurgie, Rotes</name>
      <address>
        <city>Kassel</city>
        <zip>34121</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Migraine- und Kopfschmerzklinik Konigstein</name>
      <address>
        <city>Konigstein</city>
        <zip>D-61462</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologie &amp; Kopfschmerzzentrum Munchner Freiheit</name>
      <address>
        <city>Munich</city>
        <zip>80802</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Munich-Klinikum der Universitat Munchen Neurologische Klinik und Poliklinik</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Munster, Klinik und Poliklinik fur Neurologie</name>
      <address>
        <city>Munster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>June 25, 2018</last_update_submitted>
  <last_update_submitted_qc>June 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</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>Cluster Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_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/NCT01677026
org study id: CP-004
nct id: NCT01677026
lead sponsor: 
has dmc: No
The primary objectives of the Registry are to:

        1. Monitor the transfer of the ATI Neurostimulation System and its safety/clinical
           performance to a larger number of centers in the post market phase and

        2. Collect additional evidence to support reimbursement and clinical acceptance and long
           term follow up
observational model: Case-Only
time perspective: Prospective
measure: Character of usability and acceptance of the ATI Neurostimulation System, as evaluated by the following:
time frame: Through study completion
description: Implantation of ATI Neurostimulator within the pterygopalatine fossa
Explant and lead-revision rates and reasons
measure: Characterization of patient response to therapy, as evaluated by the following:
time frame: Through study completion
description: Patient acceptance of the therapy
Responder Analysis, where a responder is any patient who achieves Effective Therapy in at least 50% of evaluable attacks, a 50% attack frequency attack decrease relative to Baseline, or both
Disability and Quality of Life as characterized by the HIT-6 and SF-36v2 compared to Baseline
Subject Overall Evaluation of Therapy
Change in use of acute medications compared to Baseline
Change in preventive medication use and work status compared to Baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Arne May, MD, PhD
role: Principal Investigator
affiliation: Institut fur systemische Neurowissenschaften, Universitastsklinikum Hamburg-Eppendorf (UKE)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Germany
responsible party type: Sponsor
mesh term: Cluster Headache
mesh term: Headache