<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/NCT01664013</url>
  </required_header>
  <id_info>
    <org_study_id>MT_IT_010</org_study_id>
    <nct_id>NCT01664013</nct_id>
  </id_info>
  <brief_title>The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients</brief_title>
  <official_title>The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roongroj Bhidayasiri</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the impact of botulinum toxin treatment in&#xD;
      quality of life(QoL) in cervical dystonia patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">October 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.</measure>
    <time_frame>6 weeks</time_frame>
    <description>To investigate the change of quality of life of cervical dystonia patients from baseline at 6 weeks after botulinum toxin treatment measured by CDQ-24.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)</measure>
    <time_frame>6 weeks</time_frame>
    <description>To investigate the change of QoL of cervical dystonia patients at 6weeks after botulinum toxin treatment from baseline measured by SF-36 (Thai version).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score</measure>
    <time_frame>6 weeks</time_frame>
    <description>To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Botulinum Toxin</condition>
  <condition>Quality of Life</condition>
  <condition>Cervical Dystonia</condition>
  <arm_group>
    <arm_group_label>Neuronox</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neuronox® is a botulinum toxin type A (BoNT/A) product developed by Medytox Inc. (Medytox) of Korea. Neuronox® was first approved by the Korean Food and Drug Administration in 2006, and by Thai Food and Drug Administration in 2008.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nuronox</intervention_name>
    <description>Reconstituted Neuronox® is injected at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.Actual dose and injection site should be adjusted individually considering the muscle mass, degree of spasticity, body weight, and response to any previous botulinum toxin injections.</description>
    <arm_group_label>Neuronox</arm_group_label>
    <other_name>Clostridium Botulinum Toxin A</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged ≥ 18 years to 75 years&#xD;
&#xD;
          -  Subjects requiring treatment for a clinical diagnosis of cervical dystonia&#xD;
&#xD;
          -  Willing to provide written informed consent before any study-related procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pure anterocollis&#xD;
&#xD;
          -  Patients with an anaphlyactic response history to botulinum toxin type A.&#xD;
&#xD;
          -  Patients who have been treated with botulinum toxin type A within 3 month.&#xD;
&#xD;
          -  Females who are pregnant, planning pregnancy, unable to use contraception or&#xD;
             lactating.&#xD;
&#xD;
          -  Any medical condition that may put the subject at increased risk with exposure to&#xD;
             botulinum toxin at the discrimination of investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Roongroj Bhidayasiri, MD</last_name>
    <phone>+662 2564630</phone>
    <email>rbh1@ucla.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Roongroj Bhidayasiri</name>
      <address>
        <city>Pathumwan</city>
        <state>Bangkok</state>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roongroj Bhidayasiri, MD</last_name>
      <phone>+662 2564630</phone>
      <email>rbh1@ucla.du</email>
    </contact>
    <investigator>
      <last_name>Roongroj Bhidayasiri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 18, 2013</last_update_submitted>
  <last_update_submitted_qc>August 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Roongroj Bhidayasiri</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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>Torticollis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_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/NCT01664013
org study id: MT_IT_010
nct id: NCT01664013
lead sponsor: 
The purpose of this study is to investigate the impact of botulinum toxin treatment in
      quality of life(QoL) in cervical dystonia patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.
time frame: 6 weeks
description: To investigate the change of quality of life of cervical dystonia patients from baseline at 6 weeks after botulinum toxin treatment measured by CDQ-24.
measure: To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)
time frame: 6 weeks
description: To investigate the change of QoL of cervical dystonia patients at 6weeks after botulinum toxin treatment from baseline measured by SF-36 (Thai version).
measure: To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score
time frame: 6 weeks
description: To Investigate the change of symptom at 6weeks after botulinum toxin treatment from baseline measured by TWSTRS score
arm group label: Neuronox
arm group type: Experimental
description: Neuronox® is a botulinum toxin type A (BoNT/A) product developed by Medytox Inc. (Medytox) of Korea. Neuronox® was first approved by the Korean Food and Drug Administration in 2006, and by Thai Food and Drug Administration in 2008.
intervention type: Drug
intervention name: Nuronox
description: Reconstituted Neuronox® is injected at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.Actual dose and injection site should be adjusted individually considering the muscle mass, degree of spasticity, body weight, and response to any previous botulinum toxin injections.
arm group label: Neuronox
other name: Clostridium Botulinum Toxin A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Roongroj Bhidayasiri, MD
phone: +662 2564630
email: rbh1@ucla.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: Thailand
responsible party type: Sponsor-Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Roongroj Bhidayasiri
investigator title: Associate Professor
mesh term: Dystonia
mesh term: Dystonic Disorders
mesh term: Torticollis
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA