<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/NCT03776318</url>
  </required_header>
  <id_info>
    <org_study_id>STX-015-18-02</org_study_id>
    <nct_id>NCT03776318</nct_id>
  </id_info>
  <brief_title>Long-Term Follow-up Safety of Clonidine Micropellets</brief_title>
  <acronym>RePRIEVE-CM-LT</acronym>
  <official_title>A Multicenter, Randomized, Follow-up Study to Evaluate the Long-Term Safety of Clonidine Micropellets for the Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sollis Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sollis Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months&#xD;
      post injection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Average and Worst NRS from Day 60 post injection to 12 months post injection</measure>
    <time_frame>10 months from completing Day 60 of the STX-015-18-01 study</time_frame>
    <description>Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Surgeries</measure>
    <time_frame>12 months from day of injection</time_frame>
    <description>Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Invasive treatment received</measure>
    <time_frame>12 months from day of injection</time_frame>
    <description>Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Prescription medications taken</measure>
    <time_frame>12 months from day of injection</time_frame>
    <description>Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Lumbosacral Radiculopathy</condition>
  <arm_group>
    <arm_group_label>Safety Group</arm_group_label>
    <description>STX-015-18-01 Clonidine Micropellet long-term safety follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Control</arm_group_label>
    <description>STX-015-18-01 Sham control long-term safety follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Long-Term Safety Follow-up</intervention_name>
    <description>STX-015-18-01 long-term safety follow-up</description>
    <arm_group_label>Safety Group</arm_group_label>
    <arm_group_label>Sham Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Comprised of the first 100 subjects who completed all STX-015-18-01 study-related&#xD;
        activities, age 18-70, male/female, reconfirmed eligible and signed informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject who have successfully completed all STX-015-18-01 study related activities,&#xD;
             are reconfirmed to be eligible and have signed informed consent to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, have demonstrated significant&#xD;
             non-compliance with STX-015-18-01 study procedures.&#xD;
&#xD;
          -  Subjects who were unblinded to their treatment in STX-015-18-01 study.&#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>Christopher Gilligan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 36</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 44</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 40</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 49</name>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 30</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>22205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 35</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 38</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 12</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 13</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 14</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 37</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 10</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 15</name>
      <address>
        <city>Brookline</city>
        <state>Massachusetts</state>
        <zip>02445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 17</name>
      <address>
        <city>Shrewsbury</city>
        <state>New Jersey</state>
        <zip>07702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 31</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 18</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 21</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 33</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 19</name>
      <address>
        <city>Edmond</city>
        <state>Oklahoma</state>
        <zip>73013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 46</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 42</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 34</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 47</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 23</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sollis Clinical Study Site 27</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 12, 2019</last_update_submitted>
  <last_update_submitted_qc>December 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</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>Radiculopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03776318
org study id: STX-015-18-02
nct id: NCT03776318
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Long-term follow-up study to evaluate the safety of clonidine micropellets up to 12 months
      post injection.
observational model: Cohort
time perspective: Prospective
measure: Change in Average and Worst NRS from Day 60 post injection to 12 months post injection
time frame: 10 months from completing Day 60 of the STX-015-18-01 study
description: Difference in NRS pain scores from Day 60 of STX-015-18-01 to month 12 post injection
measure: Incidence of Surgeries
time frame: 12 months from day of injection
description: Difference in incidence of surgery, invasive treatment, and prescription medications due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01.
measure: Incidence of Invasive treatment received
time frame: 12 months from day of injection
description: Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01
measure: Number of Prescription medications taken
time frame: 12 months from day of injection
description: Difference in incidence of invasive treatment due to radicular leg pain from Day 30 post injection to month 12 post injection from a cohort of subjects completing STX-015-18-01
arm group label: Safety Group
description: STX-015-18-01 Clonidine Micropellet long-term safety follow-up
arm group label: Sham Control
description: STX-015-18-01 Sham control long-term safety follow-up
intervention type: Drug
intervention name: Long-Term Safety Follow-up
description: STX-015-18-01 long-term safety follow-up
arm group label: Safety Group
arm group label: Sham Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Christopher Gilligan, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
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country: United States
responsible party type: Sponsor
mesh term: Radiculopathy
sharing ipd: Undecided