<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/NCT01686061</url>
  </required_header>
  <id_info>
    <org_study_id>MUS6020100920</org_study_id>
    <nct_id>NCT01686061</nct_id>
  </id_info>
  <brief_title>Blepharospasm Patient Survey for Patients With Blepharospasm</brief_title>
  <official_title>Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merz Pharmaceuticals GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merz North America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merz Pharmaceuticals GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this survey is to collect detailed information on patients treated for&#xD;
      blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including&#xD;
      how often they are treated with botulinum toxin, how long their treatment lasts, how&#xD;
      satisfied they are with their treatment, and if there is any improvement in their symptoms&#xD;
      with the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is open to males and females &gt; 18 years and &lt; 81 years with a clinical diagnosis&#xD;
      of blepharospasm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Botulinum Toxin Treatment Information</measure>
    <time_frame>This is a single, structured interview about experiences with Botulinum Toxins</time_frame>
    <description>The following information for patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA, or onabotulinumtoxinA treatment is collected: (1) botulinum treatment information such as intervals for botulinum injections, physician's rationale for injection interval, overall experience with botulinum toxin injections (onset, maximum effect, decline of effect), current injection cycle experience (current satisfaction, satisfaction at maximum effect, and visual analog scale (VAS) of current health status); and (2) disability status using the Blepharospasm Disability Index (BSDI) and the Jankovic Rating Scale (JRS)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">124</enrollment>
  <condition>Blepharospasm</condition>
  <arm_group>
    <arm_group_label>Blepharospasm Survey Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention- only one time survey</intervention_name>
    <arm_group_label>Blepharospasm Survey Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or&#xD;
        onabotulinumtoxinA treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject aged &gt; 18 years and &lt; 81 years&#xD;
&#xD;
          -  Documented clinical diagnosis of blepharospasm&#xD;
&#xD;
          -  Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>81 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Micki Seoane</last_name>
    <role>Study Director</role>
    <affiliation>Merz Pharmaceutical, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Merz Investigative Site #0007</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site # 0002</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site # 0001</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site #003</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merz Investigative Site # 0006</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</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>Blepharospasm</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/NCT01686061
org study id: MUS6020100920
nct id: NCT01686061
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this survey is to collect detailed information on patients treated for
      blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including
      how often they are treated with botulinum toxin, how long their treatment lasts, how
      satisfied they are with their treatment, and if there is any improvement in their symptoms
      with the treatment.
This study is open to males and females > 18 years and < 81 years with a clinical diagnosis
      of blepharospasm.
observational model: Other
time perspective: Other
measure: Botulinum Toxin Treatment Information
time frame: This is a single, structured interview about experiences with Botulinum Toxins
description: The following information for patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA, or onabotulinumtoxinA treatment is collected: (1) botulinum treatment information such as intervals for botulinum injections, physician's rationale for injection interval, overall experience with botulinum toxin injections (onset, maximum effect, decline of effect), current injection cycle experience (current satisfaction, satisfaction at maximum effect, and visual analog scale (VAS) of current health status); and (2) disability status using the Blepharospasm Disability Index (BSDI) and the Jankovic Rating Scale (JRS)
arm group label: Blepharospasm Survey Group
intervention type: Other
intervention name: No intervention- only one time survey
arm group label: Blepharospasm Survey Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 81 Years
healthy volunteers: No
last name: Micki Seoane
role: Study Director
affiliation: Merz Pharmaceutical, LLC
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Blepharospasm