<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/NCT03234413</url>
  </required_header>
  <id_info>
    <org_study_id>KU GOKAEK 2017/91</org_study_id>
    <nct_id>NCT03234413</nct_id>
  </id_info>
  <brief_title>Safety on Switching Between Different Botulinum Toxin-A</brief_title>
  <official_title>Switching Between Different Types of Botulinum Toxin-A in Children With Cerebral Palsy Treated for Spasticity: a Safety Retrospective Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nigar Dursun</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental&#xD;
      spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of&#xD;
      Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the&#xD;
      two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.&#xD;
&#xD;
      With this study investigators would like to evaluate retrospectively if switching from one&#xD;
      toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin&#xD;
      to another was maintained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A data base was designed to capture all data that were considered relevant to the treatment&#xD;
      evaluation. The data were transcribed directly from participants medical records. For the&#xD;
      purpose of the study, data from the two subsequent visits where a different type of toxin was&#xD;
      given will be collected and evaluated . In order to collect the pre and post status in terms&#xD;
      of safety and efficacy, for each participant, data corresponding to the 6 previous and&#xD;
      posterior months after the switch of the toxin will also be collected or data corresponding&#xD;
      to the previous and posterior visit after the switch of the toxin will also be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2017</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurence of treatment related adverse events</measure>
    <time_frame>Up to 30 months</time_frame>
    <description>Overall and per injection cycle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>Up to 30 months</time_frame>
    <description>Spasticity Assessment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tardieu Scale</measure>
    <time_frame>Up to 30 months</time_frame>
    <description>Spasticity Assessment Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observational Gait Scale</measure>
    <time_frame>Up to 30 months</time_frame>
    <description>Gait Assessment Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Goal Attainment Scale</measure>
    <time_frame>Up to 30 months</time_frame>
    <description>Outcome measure for goal selection and goal scaling</description>
  </other_outcome>
  <enrollment type="Actual">118</enrollment>
  <condition>Cerebral Palsy</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin type A</intervention_name>
    <description>Botulinum toxin type A</description>
    <other_name>Botox, Dysport</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        No active study treatment will be given as this will be a retrospective study. Information&#xD;
        on children with at least two subsequent injection of two different types of toxinA for the&#xD;
        treatment of spasticity will be collected and analysed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children diagnosis of cerebral palsy with respect to Rosenbaum criteria,&#xD;
&#xD;
          -  children having received repeated injections with two different types of toxinA&#xD;
             treatment into their lower limb(s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children without repeated Botulinum toxin type A injections&#xD;
&#xD;
          -  children having received repeated injections with same type of toxinA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nigar Dursun, MD</last_name>
    <role>Study Director</role>
    <affiliation>Kocaeli University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli University</name>
      <address>
        <city>Kocaeli</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 4, 2018</last_update_submitted>
  <last_update_submitted_qc>January 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Nigar Dursun</investigator_full_name>
    <investigator_title>Professor, MD</investigator_title>
  </responsible_party>
  <keyword>Botulinum Toxin-A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</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>
  <patient_data>
    <sharing_ipd>No</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/NCT03234413
org study id: KU GOKAEK 2017/91
nct id: NCT03234413
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental
      spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of
      Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the
      two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.

      With this study investigators would like to evaluate retrospectively if switching from one
      toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin
      to another was maintained.
A data base was designed to capture all data that were considered relevant to the treatment
      evaluation. The data were transcribed directly from participants medical records. For the
      purpose of the study, data from the two subsequent visits where a different type of toxin was
      given will be collected and evaluated . In order to collect the pre and post status in terms
      of safety and efficacy, for each participant, data corresponding to the 6 previous and
      posterior months after the switch of the toxin will also be collected or data corresponding
      to the previous and posterior visit after the switch of the toxin will also be collected.
observational model: Case-Only
time perspective: Retrospective
measure: Occurence of treatment related adverse events
time frame: Up to 30 months
description: Overall and per injection cycle
measure: Modified Ashworth Scale
time frame: Up to 30 months
description: Spasticity Assessment Scale
measure: Tardieu Scale
time frame: Up to 30 months
description: Spasticity Assessment Scale
measure: Observational Gait Scale
time frame: Up to 30 months
description: Gait Assessment Scale
measure: Goal Attainment Scale
time frame: Up to 30 months
description: Outcome measure for goal selection and goal scaling
intervention type: Drug
intervention name: Botulinum toxin type A
description: Botulinum toxin type A
other name: Botox, Dysport
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
last name: Nigar Dursun, MD
role: Study Director
affiliation: Kocaeli University
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Kocaeli University
investigator full name: Nigar Dursun
investigator title: Professor, MD
mesh term: Cerebral Palsy
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No