<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/NCT02221648</url>
  </required_header>
  <id_info>
    <org_study_id>1210011010</org_study_id>
    <nct_id>NCT02221648</nct_id>
  </id_info>
  <brief_title>Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain</brief_title>
  <official_title>Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA&#xD;
      (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.&#xD;
&#xD;
      The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A&#xD;
      into erector spinae muscles (extensors of the spine) can relieve low back pain through&#xD;
      anti-spasm and analgesic effect of botulinum toxin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an investigator initiated, randomized, double blind, placebo-controlled study. A&#xD;
      total of 90 patients will be enrolled in the study. The study will be conducted over 4&#xD;
      months. It includes 4 visits and 4 telephone calls. Patients with chronic low back pain (&gt;3&#xD;
      months) who meet inclusion and exclusion criteria and wish to participate in the study may be&#xD;
      enrolled. Those who become enrolled will be scheduled for a baseline visit (Week 0). During&#xD;
      the baseline visit, subjects will be given the official approved consent form to read and ask&#xD;
      questions. Participants to this study will also receive a copy of the Dysport Risk Evaluation&#xD;
      and Mitigation Strategy (REMS) statement. After obtaining informed consent signed by the&#xD;
      subject, the subjects will be randomization into the Dysport or placebo group. The&#xD;
      randomizing will be performed by a nurse and the information will be kept in a pass-worded&#xD;
      computer. Blinding means that neither the participant nor the clinical rater will know which&#xD;
      group the participant has been initially been assigned.&#xD;
&#xD;
      Each subject will have a neurological examination and fill a demographic form and complete&#xD;
      four rating questionnaires (appendix II-V). These include a visual analogue scale for pain (0&#xD;
      to 10) and three quality of life questionnaires which depict quality of life (the American&#xD;
      Chronic Pain Association's Quality of Life Scale), how pain affects ability to manage&#xD;
      everyday life (Oswestry Low Back Pain Disability Questionnaire), and overall physical and&#xD;
      emotional health (Short Form-36). Patients will then receive an injection of either&#xD;
      abobotulinumA (Dysport) or normal saline. Dysport or saline will be administered into the&#xD;
      paraspinal muscles (extensors or erector spinae) at five levels (L1-L5), regardless of pain&#xD;
      location. In the case of unilateral pain, this would amount to 500 units total, and in the&#xD;
      case of bilateral pain, to 1000 units total, of Dysport per session.&#xD;
&#xD;
      The primary outcome of the study is number of patients with VAS &lt; 4 ( no or subtle pain) at&#xD;
      week 6 after placebo or Dysport injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI retired and moved- funding sponsor contacted and Oked&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The primary outcome measure in this protocol is the proportion of subjects that have VAS &lt;4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by &quot;no pain&quot; (score of 0) and &quot;worst imaginable pain&quot; (score of 10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:&#xD;
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)&#xD;
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Showing Improvement on Quality of Life Scale for Pain</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Lower Back Pain</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AbobotulinumtoxinA Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will be randomization to receive either the study drug or the placebo group.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AbobotulinumtoxinA Treatment</intervention_name>
    <description>Subjects receive intervention injections with the study drug arbobotulinumtoxinA.</description>
    <arm_group_label>AbobotulinumtoxinA Treatment</arm_group_label>
    <other_name>Dysport</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80, all ethnic groups, races, both sexes.&#xD;
&#xD;
          -  Diagnosis of chronic low back pain (longer than 3 months).&#xD;
&#xD;
          -  Pain of moderate to severe intensity (VAS 4 or higher).&#xD;
&#xD;
          -  Subjects who are able to read, speak, and understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic,&#xD;
        neoplastic, infectious, or autoimmune disorders).&#xD;
&#xD;
          -  Hypersensitivity to any botulinum toxin product or is recipient&#xD;
&#xD;
          -  Allergy to albumin. Lactose or cow milk protein&#xD;
&#xD;
          -  Infection in the proposed injection site.&#xD;
&#xD;
          -  Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of&#xD;
             childbearing age should use a reliable mode of contraception during the study period&#xD;
             (abstinence, etc).&#xD;
&#xD;
          -  Active breast feeding.&#xD;
&#xD;
          -  Enrollment in any clinical trial (currently or within the past 3 months) in which&#xD;
             treatments are imposed by a protocol.&#xD;
&#xD;
          -  Patients taking high doses of aminoglycosides or other drugs affecting the function of&#xD;
             neuromuscular junction (anticholinergics , muscle relaxants)&#xD;
&#xD;
          -  Subjects who are younger than 18 years of age.&#xD;
&#xD;
          -  Neuromuscular-junction disorders and motor neuron disease such as Amyotrophic Lateral&#xD;
             Sclerosis.&#xD;
&#xD;
          -  Evidence of acute pathology on neuro-imaging.&#xD;
&#xD;
          -  Axis I diagnosis determined by a neurologist or psychiatrist.&#xD;
&#xD;
          -  Anesthetic medications within two weeks and corticosteroid injections within 4 weeks&#xD;
             of enrollment.&#xD;
&#xD;
          -  Received botulinum toxin injections in the past 3 months.&#xD;
&#xD;
          -  History of low back surgery , evidence of acute disc or severe lumbar stenosis in MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bahman Jabbari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Medical Group</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>April 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <results_first_submitted>September 7, 2015</results_first_submitted>
  <results_first_submitted_qc>February 9, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 8, 2016</results_first_posted>
  <last_update_submitted>July 18, 2016</last_update_submitted>
  <last_update_submitted_qc>July 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Back</keyword>
  <keyword>Pain</keyword>
  <keyword>Muscle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>abobotulinumtoxinA</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Due to relocation of PI, study was terminated with 43 enrollments(total).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.</description>
        </group>
        <group group_id="P2">
          <title>ArbobotulinumtoxinA Treatment</title>
          <description>Subjects will receive intervention injections with the study drug abobotulinumtoxinA.&#xD;
AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Subjects will be randomization to receive injections with either the study drug (incobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.</description>
        </group>
        <group group_id="B2">
          <title>AbobotulinumtoxinA Treatment</title>
          <description>All subjects will receive intervention injections with the study drug abobotulinumtoxinA.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="37"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </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="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </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="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)</title>
        <description>The primary outcome measure in this protocol is the proportion of subjects that have VAS &lt;4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by &quot;no pain&quot; (score of 0) and &quot;worst imaginable pain&quot; (score of 10).</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects will be randomized to receive injections with saline.</description>
          </group>
          <group group_id="O2">
            <title>AbobotulinumtoxinA Treatment</title>
            <description>All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)</title>
          <description>The primary outcome measure in this protocol is the proportion of subjects that have VAS &lt;4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by &quot;no pain&quot; (score of 0) and &quot;worst imaginable pain&quot; (score of 10).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4470</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)</title>
        <description>The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:&#xD;
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)&#xD;
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Study group received placebo injection.</description>
          </group>
          <group group_id="O2">
            <title>botulinumtoxinA Treatment</title>
            <description>Subjects received botox injection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)</title>
          <description>The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:&#xD;
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)&#xD;
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0293</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Showing Improvement on Quality of Life Scale for Pain</title>
        <description>The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.&#xD;
Placebo: Subjects will be randomization to receive either the study drug or the placebo group.</description>
          </group>
          <group group_id="O2">
            <title>AbobotulinumtoxinA Treatment</title>
            <description>Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.&#xD;
AbobotulinumtoxinA Treatment: Subjects receive intervention injections with the study drug arbobotulinumtoxinA.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Showing Improvement on Quality of Life Scale for Pain</title>
          <description>The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0448</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Subjects will be randomized to receive injections with placebo.</description>
        </group>
        <group group_id="E2">
          <title>ArbobotulinumtoxinA Treatment</title>
          <description>AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.</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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="18"/>
              </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>
    <limitations_and_caveats>This study was terminated due to relocation of the PI. The initial goal was enrolling 90 patients. The number enrolled at the time of termination was 43, with 37 completed the study. Results may not provide enough statistical power.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Bahman Jabbari M.D, , Professor of Neurology</name_or_title>
      <organization>Yale University School of Medicine</organization>
      <phone>203-737-2464</phone>
      <email>bahman.jabbari@yale.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/NCT02221648
org study id: 1210011010
nct id: NCT02221648
lead sponsor: 
collaborator: 
has dmc: No
The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA
      (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.

      The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A
      into erector spinae muscles (extensors of the spine) can relieve low back pain through
      anti-spasm and analgesic effect of botulinum toxin.
This is an investigator initiated, randomized, double blind, placebo-controlled study. A
      total of 90 patients will be enrolled in the study. The study will be conducted over 4
      months. It includes 4 visits and 4 telephone calls. Patients with chronic low back pain (>3
      months) who meet inclusion and exclusion criteria and wish to participate in the study may be
      enrolled. Those who become enrolled will be scheduled for a baseline visit (Week 0). During
      the baseline visit, subjects will be given the official approved consent form to read and ask
      questions. Participants to this study will also receive a copy of the Dysport Risk Evaluation
      and Mitigation Strategy (REMS) statement. After obtaining informed consent signed by the
      subject, the subjects will be randomization into the Dysport or placebo group. The
      randomizing will be performed by a nurse and the information will be kept in a pass-worded
      computer. Blinding means that neither the participant nor the clinical rater will know which
      group the participant has been initially been assigned.

      Each subject will have a neurological examination and fill a demographic form and complete
      four rating questionnaires (appendix II-V). These include a visual analogue scale for pain (0
      to 10) and three quality of life questionnaires which depict quality of life (the American
      Chronic Pain Association's Quality of Life Scale), how pain affects ability to manage
      everyday life (Oswestry Low Back Pain Disability Questionnaire), and overall physical and
      emotional health (Short Form-36). Patients will then receive an injection of either
      abobotulinumA (Dysport) or normal saline. Dysport or saline will be administered into the
      paraspinal muscles (extensors or erector spinae) at five levels (L1-L5), regardless of pain
      location. In the case of unilateral pain, this would amount to 500 units total, and in the
      case of bilateral pain, to 1000 units total, of Dysport per session.

      The primary outcome of the study is number of patients with VAS < 4 ( no or subtle pain) at
      week 6 after placebo or Dysport injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)
time frame: 6 weeks
description: The primary outcome measure in this protocol is the proportion of subjects that have VAS <4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
measure: Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)
time frame: 6 weeks
description: The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment
measure: Number of Subjects Showing Improvement on Quality of Life Scale for Pain
time frame: 6 weeks
description: The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.
arm group label: AbobotulinumtoxinA Treatment
arm group type: Active Comparator
description: Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.
intervention type: Drug
intervention name: Placebo
description: Subjects will be randomization to receive either the study drug or the placebo group.
arm group label: Placebo
intervention type: Drug
intervention name: AbobotulinumtoxinA Treatment
description: Subjects receive intervention injections with the study drug arbobotulinumtoxinA.
arm group label: AbobotulinumtoxinA Treatment
other name: Dysport
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bahman Jabbari, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: abobotulinumtoxinA
mesh term: Botulinum Toxins, Type A
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated due to relocation of the PI. The initial goal was enrolling 90 patients. The number enrolled at the time of termination was 43, with 37 completed the study. Results may not provide enough statistical power.
point of contact: 