<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/NCT01728428</url>
  </required_header>
  <id_info>
    <org_study_id>116414</org_study_id>
    <nct_id>NCT01728428</nct_id>
  </id_info>
  <brief_title>A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the clinical manifestation, diagnosis and treatment options of primary&#xD;
      hemifacial spasm in Chinese outpatient subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically&#xD;
      diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent&#xD;
      has been obtained. The exclusion criteria include secondary hemifacial spasm, other&#xD;
      involuntary facial movement disorder, history of surgery of microvascular decompression of&#xD;
      the facial nerve and so on. The outcome measures include the percentage of the treatment&#xD;
      methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom,&#xD;
      concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of the treatment methods of HFS in outpatient subjects</measure>
    <time_frame>November, 2012</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distribution of onset age of hemifacial spasm patients</measure>
    <time_frame>November, 2012</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of aggrevated and relieved factors of HFS symptom</measure>
    <time_frame>November, 2012</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of concomitant symptoms of hemifacial spasm</measure>
    <time_frame>November, 2012</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events of botulinum toxin treatment in hemifacial spasm</measure>
    <time_frame>November, 2012</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1003</enrollment>
  <condition>Hemifacial Spasm</condition>
  <eligibility>
    <study_pop>
      <textblock>
        About 1000 Outpatient subjects from 15 centers across China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Clinically diagnosed primary hemifacial spasm&#xD;
&#xD;
          1. Tonic and clonic contractions of muscles innervated by the unilateral facial nerve.&#xD;
&#xD;
          2. No other neurological disorder. 2.Male or female 18 to 80 years old 3.Informed consent&#xD;
             has been obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on.&#xD;
&#xD;
          2. Other involuntary facial movement disorder: facial synkinesia after facial palsy,&#xD;
             tics, myokymia and focal motor seizures.&#xD;
&#xD;
          3. History of surgery of microvascular decompression of the facial nerve.&#xD;
&#xD;
          4. Participation in another clinical study currently.&#xD;
&#xD;
          5. Not able to understand and answer questionnaire.&#xD;
&#xD;
          6. Investigator's opinion that the subject has a concurrent condition(s) that may&#xD;
             confound the study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Tan EK, Fook-Chong S, Lum SY, Lim E. Botulinum toxin improves quality of life in hemifacial spasm: validation of a questionnaire (HFS-30). J Neurol Sci. 2004 Apr 15;219(1-2):151-5. doi: 10.1016/j.jns.2004.01.010.</citation>
    <PMID>15050451</PMID>
  </reference>
  <reference>
    <citation>Wang A, Jankovic J. Hemifacial spasm: clinical findings and treatment. Muscle Nerve. 1998 Dec;21(12):1740-7. doi: 10.1002/(sici)1097-4598(199812)21:123.0.co;2-v.</citation>
    <PMID>9843077</PMID>
  </reference>
  <reference>
    <citation>Tan NC, Chan LL, Tan EK. Hemifacial spasm and involuntary facial movements. QJM. 2002 Aug;95(8):493-500. doi: 10.1093/qjmed/95.8.493.</citation>
    <PMID>12145388</PMID>
  </reference>
  <reference>
    <citation>Au WL, Tan LC, Tan AK. Hemifacial spasm in Singapore: clinical characteristics and patients ' perceptions. Ann Acad Med Singap. 2004 May;33(3):324-8.</citation>
    <PMID>15175773</PMID>
  </reference>
  <results_reference>
    <citation>Kenney C, Jankovic J. Botulinum toxin in the treatment of blepharospasm and hemifacial spasm. J Neural Transm (Vienna). 2008;115(4):585-91. doi: 10.1007/s00702-007-0768-7. Epub 2007 Jun 11.</citation>
    <PMID>17558461</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemifacial spasm</keyword>
  <keyword>observational study</keyword>
  <keyword>clinical manifestation</keyword>
  <keyword>treatment</keyword>
  <keyword>Chinese</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemifacial Spasm</mesh_term>
    <mesh_term>Spasm</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/NCT01728428
org study id: 116414
nct id: NCT01728428
lead sponsor: 
collaborator: 
has dmc: Yes
To determine the clinical manifestation, diagnosis and treatment options of primary
      hemifacial spasm in Chinese outpatient subjects
About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically
      diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent
      has been obtained. The exclusion criteria include secondary hemifacial spasm, other
      involuntary facial movement disorder, history of surgery of microvascular decompression of
      the facial nerve and so on. The outcome measures include the percentage of the treatment
      methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom,
      concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.
time perspective: Retrospective
measure: The percentage of the treatment methods of HFS in outpatient subjects
time frame: November, 2012
measure: Distribution of onset age of hemifacial spasm patients
time frame: November, 2012
measure: Analysis of aggrevated and relieved factors of HFS symptom
time frame: November, 2012
measure: Analysis of concomitant symptoms of hemifacial spasm
time frame: November, 2012
measure: Adverse events of botulinum toxin treatment in hemifacial spasm
time frame: November, 2012
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
citation: Tan EK, Fook-Chong S, Lum SY, Lim E. Botulinum toxin improves quality of life in hemifacial spasm: validation of a questionnaire (HFS-30). J Neurol Sci. 2004 Apr 15;219(1-2):151-5. doi: 10.1016/j.jns.2004.01.010.
PMID: 15050451
citation: Wang A, Jankovic J. Hemifacial spasm: clinical findings and treatment. Muscle Nerve. 1998 Dec;21(12):1740-7. doi: 10.1002/(sici)1097-4598(199812)21:123.0.co;2-v.
PMID: 9843077
citation: Tan NC, Chan LL, Tan EK. Hemifacial spasm and involuntary facial movements. QJM. 2002 Aug;95(8):493-500. doi: 10.1093/qjmed/95.8.493.
PMID: 12145388
citation: Au WL, Tan LC, Tan AK. Hemifacial spasm in Singapore: clinical characteristics and patients ' perceptions. Ann Acad Med Singap. 2004 May;33(3):324-8.
PMID: 15175773
citation: Kenney C, Jankovic J. Botulinum toxin in the treatment of blepharospasm and hemifacial spasm. J Neural Transm (Vienna). 2008;115(4):585-91. doi: 10.1007/s00702-007-0768-7. Epub 2007 Jun 11.
PMID: 17558461
responsible party type: Sponsor
mesh term: Hemifacial Spasm
mesh term: Spasm