<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/NCT02245958</url>
  </required_header>
  <id_info>
    <org_study_id>GMA-US-NEU-0271</org_study_id>
    <nct_id>NCT02245958</nct_id>
  </id_info>
  <brief_title>A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins&#xD;
      BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of&#xD;
      Cervical Dystonia and Blepharospasm in clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dose of Botulinum Toxin Used to Treat Cervical Dystonia</measure>
    <time_frame>4 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose of Botulinum Toxin Used to Treat Blepharospasm</measure>
    <time_frame>4 Years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Botulinum Toxin Inter-injection Intervals</measure>
    <time_frame>4 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>4 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Botulinum Toxin Dose per Patient</measure>
    <time_frame>4 Years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Cervical Dystonia</condition>
  <condition>Blepharospasm</condition>
  <arm_group>
    <arm_group_label>BOTOX®</arm_group_label>
    <description>Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xeomin®</arm_group_label>
    <description>Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>No treatment (intervention) was administered.</description>
    <arm_group_label>BOTOX®</arm_group_label>
    <arm_group_label>Xeomin®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and&#xD;
        BOTOX® in clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at&#xD;
             least 2 years&#xD;
&#xD;
          -  Treatment with Xeomin® and BOTOX® for at least 2 years each.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a neuromuscular junction transmission disorder or taking any medications that&#xD;
             could affect neuromuscular junction transmission&#xD;
&#xD;
          -  Previous surgical procedure involving bone or muscle for the management of cervical&#xD;
             dystonia or blepharospasm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Colonia Roma Z.P.</city>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wakefield</city>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>January 6, 2016</last_update_submitted>
  <last_update_submitted_qc>January 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 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>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</mesh_term>
    <mesh_term>Blepharospasm</mesh_term>
    <mesh_term>Torticollis</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/NCT02245958
org study id: GMA-US-NEU-0271
nct id: NCT02245958
lead sponsor: 
has dmc: No
This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins
      BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of
      Cervical Dystonia and Blepharospasm in clinical practice.
observational model: Cohort
time perspective: Retrospective
measure: Dose of Botulinum Toxin Used to Treat Cervical Dystonia
time frame: 4 Years
measure: Dose of Botulinum Toxin Used to Treat Blepharospasm
time frame: 4 Years
measure: Botulinum Toxin Inter-injection Intervals
time frame: 4 Years
measure: Number of Participants with Adverse Events
time frame: 4 Years
measure: Annual Botulinum Toxin Dose per Patient
time frame: 4 Years
arm group label: BOTOX®
description: Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
arm group label: Xeomin®
description: Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
intervention type: Other
intervention name: No Intervention
description: No treatment (intervention) was administered.
arm group label: BOTOX®
arm group label: Xeomin®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Allergan
facility: 
facility: 
country: Mexico
country: United Kingdom
responsible party type: Sponsor
mesh term: Dystonia
mesh term: Dystonic Disorders
mesh term: Blepharospasm
mesh term: Torticollis