<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/NCT02986880</url>
  </required_header>
  <id_info>
    <org_study_id>2011/08</org_study_id>
    <secondary_id>2011-000889-35</secondary_id>
    <nct_id>NCT02986880</nct_id>
  </id_info>
  <brief_title>Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures</brief_title>
  <official_title>A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to estimate the efficiency and to determine the optimal&#xD;
      dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after&#xD;
      radiotherapy, as well as the optimal sites for these injections.&#xD;
&#xD;
      The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the&#xD;
      splenius capitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">January 10, 2014</completion_date>
  <primary_completion_date type="Actual">January 10, 2014</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>Cervical mobility degree</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&amp;N35)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Cervical Spasm</condition>
  <condition>Radiotherapy Side Effect</condition>
  <condition>Botulinum Toxin</condition>
  <arm_group>
    <arm_group_label>Group D1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in SCM and the placebo in trapezius muscle and splenius capitis. Patients receiving the dose of 30 units (U) at injection point, totalling 120 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 60 units (U) at injection point, totalling 240 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 100 units (U) at injection point, totalling 400 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 30 units (U) at injection point, totalling 180 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 60 units (U) at injection point, totalling 360 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 100 units (U) at injection point, totalling 600 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group F3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group P</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receiving placebo in the third muscles groups</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin A</intervention_name>
    <arm_group_label>Group A1</arm_group_label>
    <arm_group_label>Group A2</arm_group_label>
    <arm_group_label>Group A3</arm_group_label>
    <arm_group_label>Group D1</arm_group_label>
    <arm_group_label>Group D2</arm_group_label>
    <arm_group_label>Group D3</arm_group_label>
    <arm_group_label>Group F1</arm_group_label>
    <arm_group_label>Group F2</arm_group_label>
    <arm_group_label>Group F3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Injection of sodium chloride (NaCl) 9/1000</description>
    <arm_group_label>Group P</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients from 18 to 75 years old;&#xD;
&#xD;
          -  malignant Tumor of aerodigestive ways, in forgiveness;&#xD;
&#xD;
          -  Treatment containing the external radiotherapy ended since &gt; 6 months&#xD;
&#xD;
          -  Life expectancy &gt; 6 months;&#xD;
&#xD;
          -  patient complaining from cervical spasms with functional disability;&#xD;
&#xD;
          -  Negative Pregnancy test;&#xD;
&#xD;
          -  Women under effective contraception;&#xD;
&#xD;
          -  Patients benefiting from a national insurance scheme;&#xD;
&#xD;
          -  Patient having given a written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cervico-facial Surgery with reconstruction by pedicled flap&#xD;
&#xD;
          -  Implantable Chamber with catheter in the internal jugular vein near the spasm;&#xD;
&#xD;
          -  Muscular, neurological Pathology or malformative pulling a disorder of perception of&#xD;
             the pain, an amyotrophy, a muscular weakness affecting the cervical axis or the upper&#xD;
             limbs;&#xD;
&#xD;
          -  Disorder generalized by the muscular activity (ex myasthenia);&#xD;
&#xD;
          -  Cervical osseous or muscular Pathology pulling pains and disability before the&#xD;
             beginning of the treatment (cervical degenerative osteoarthritis diagnosed to the&#xD;
             cervical radiography, the slipped disc);&#xD;
&#xD;
          -  Previous cervical injection of botulinum toxin ;&#xD;
&#xD;
          -  Local Infection at the level of one of the sites proposed for injection;&#xD;
&#xD;
          -  Histories of epilepsy;&#xD;
&#xD;
          -  Patients presenting a hypersensitivity to the botulinum neurotoxin A or in one of its&#xD;
             excipients;&#xD;
&#xD;
          -  Patients under anticoagulation therapy, Under antibiotic treatment by aminoglycosides&#xD;
             or amino 4 quinoline, under myorelaxant treatment or that must undergo an intervention&#xD;
             with curarisation;&#xD;
&#xD;
          -  Patients for whom a surgical operation is planned in the zone interested in the&#xD;
             treatment&#xD;
&#xD;
          -  Pregnant or breast-feeding Women;&#xD;
&#xD;
          -  Patients for whom questionnaires will not be assessable (handicaps of communication,&#xD;
             patient not speaking French, etc.).&#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_official>
    <last_name>Christine Bach</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2017</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>Contracture</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>
  <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/NCT02986880
org study id: 2011/08
secondary id: 2011-000889-35
nct id: NCT02986880
lead sponsor: 
has dmc: No
The main objective of the study is to estimate the efficiency and to determine the optimal
      dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after
      radiotherapy, as well as the optimal sites for these injections.

      The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the
      splenius capitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Cervical mobility degree
time frame: 6 months
measure: Quality of Life Questionnaire Module for Head and Neck Cancer (QLQ-H&N35)
time frame: 6 months
arm group label: Group D1
arm group type: Experimental
description: Patients receiving the toxin in SCM and the placebo in trapezius muscle and splenius capitis. Patients receiving the dose of 30 units (U) at injection point, totalling 120 U.
arm group label: Group D2
arm group type: Experimental
description: Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 60 units (U) at injection point, totalling 240 U.
arm group label: Group D3
arm group type: Experimental
description: Patients receiving the toxin in the SCM and the placebo in the trapezius muscle and the splenius capitis. Patients receiving the dose of 100 units (U) at injection point, totalling 400 U.
arm group label: Group A1
arm group type: Experimental
description: Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 30 units (U) at injection point, totalling 180 U.
arm group label: Group A2
arm group type: Experimental
description: Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 60 units (U) at injection point, totalling 360 U.
arm group label: Group A3
arm group type: Experimental
description: Patients receiving the toxin in trapezius muscle and splenius capitis and the placebo in SCM . Patients receiving the dose of 100 units (U) at injection point, totalling 600 U.
arm group label: Group F1
arm group type: Experimental
description: Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 30 units (U) at injection point, totalling 300 U.
arm group label: Group F2
arm group type: Experimental
description: Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 60 units (U) at injection point, totalling 600 U.
arm group label: Group F3
arm group type: Experimental
description: Patients receiving the toxin in the third muscles groups. Patients receiving the dose of 100 units (U) at injection point, totalling 1000 U.
arm group label: Group P
arm group type: Placebo Comparator
description: Patients receiving placebo in the third muscles groups
intervention type: Drug
intervention name: Botulinum toxin A
arm group label: Group A1
arm group label: Group A2
arm group label: Group A3
arm group label: Group D1
arm group label: Group D2
arm group label: Group D3
arm group label: Group F1
arm group label: Group F2
arm group label: Group F3
intervention type: Procedure
intervention name: Placebo
description: Injection of sodium chloride (NaCl) 9/1000
arm group label: Group P
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Christine Bach
role: Principal Investigator
affiliation: Hopital Foch
facility: 
country: France
responsible party type: Sponsor
mesh term: Contracture
mesh term: Torticollis
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: No