<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/NCT03781700</url>
  </required_header>
  <id_info>
    <org_study_id>FACE-01</org_study_id>
    <secondary_id>2017-004187-35</secondary_id>
    <nct_id>NCT03781700</nct_id>
  </id_info>
  <brief_title>Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy</brief_title>
  <acronym>FACE</acronym>
  <official_title>The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalarna County Council, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dalarna County Council, Sweden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these&#xD;
      children will have persistent symptoms with excessive tear secretion, drooling and social&#xD;
      problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with&#xD;
      acute facial nerve palsy have shown beneficial effects, but no studies with strong quality&#xD;
      have been performed in children.&#xD;
&#xD;
      Investigators will perform a double-blind randomized placebo-controlled multicenter trial on&#xD;
      children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12&#xD;
      study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10&#xD;
      days (or placebo) will be started on admission. Clinical data, including recovery will be&#xD;
      followed-up until 12 months.&#xD;
&#xD;
      The primary outcome is defined as total recovery of the facial nerve palsy, measured with the&#xD;
      House-Brackmann scale (grade 1) at 12-months follow-up.&#xD;
&#xD;
      The overall purpose is to assess the utility of cortisone treatment given to children with&#xD;
      acute facial nerve palsy in this study. If the total recovery rate is significantly improved&#xD;
      in the prednisolone group as compared to the placebo group, prednisolone treatment will be&#xD;
      introduced in clinical practice for children with acute facial nerve palsy in order to reduce&#xD;
      the risk of persistent symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 3, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>House-Brackmann scale</measure>
    <time_frame>At 12 months (+/- 2 weeks) after inclusion</time_frame>
    <description>Total recovery in the two treatment groups measured with the House-Brackmann scale.&#xD;
The House-Brackmann scale (I is normal function and VI is total loss of function) is chosen as primary outcome measure since it is an objective instrument, easy to perform and the one most frequently used in previous studies. The time point 12 months for evaluation of total recovery is chosen as no further improvement of the facial nerve function is expected after 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sunnybrook facial grading system</measure>
    <time_frame>At 12 months (+/- 2 weeks) after inclusion</time_frame>
    <description>Total recovery in the two treatment groups measured with the Sunnybrook scale.&#xD;
The Sunnybrook scale (100 is normal function and 0 is total loss of function) is another objective scale for grading the facial nerve function. It will be used as secondary outcome measure. It is easy to perform and has been used in previous studies in children. It correlates well to the House-Brackmann scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facial Disability Index (FDI)</measure>
    <time_frame>At 12 months (+/- 2 weeks) after inclusion</time_frame>
    <description>Disease-specific Quality-of-Life assessment scale, with 5 functional domains (5 means no probelms and 2 or 1 means problems all the time) and 5 social domains (6 means problems all the time and 1 means no problems at all)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facial Clinimetric Evaluation (FaCE) Scale</measure>
    <time_frame>At 12 months (+/- 2 weeks) after inclusion</time_frame>
    <description>Disease-specific Quality-of-Life assessment scale, with 15 functional and social domains (1 means problems all the time and 5 means no problems at all).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Synkinesis Assessment Questionnaire (SAQ)</measure>
    <time_frame>At 12 month (+/- 2 weeks) after inclusion</time_frame>
    <description>Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 12 month (+/- 2 weeks) after inclusion</time_frame>
    <description>Number of Adverse Events possibly or probably related to the study drug.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Facial Palsy</condition>
  <condition>Facial Nerve Diseases</condition>
  <condition>Borrelia Infection of Central Nervous System</condition>
  <condition>Bell Palsy</condition>
  <arm_group>
    <arm_group_label>Prednisolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prednisolone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone</intervention_name>
    <description>Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.</description>
    <arm_group_label>Prednisolone</arm_group_label>
    <other_name>Batch 18A71, Orifarm Generics A/S</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo tablets with identical appearance to the experimental drug</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Batch 18A61, Orifarm Generics A/S</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 1-17 years of age&#xD;
&#xD;
          2. Acute peripheral unilateral facial nerve palsy&#xD;
&#xD;
          3. Less than 72 hours since debut of symptoms&#xD;
&#xD;
          4. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Head trauma &lt;1 month&#xD;
&#xD;
          2. Central or bilateral facial nerve palsy&#xD;
&#xD;
          3. Malformations in head and neck&#xD;
&#xD;
          4. Conditions not compatible with cortisone treatment (arterial hypertension, diabetes&#xD;
             mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)&#xD;
&#xD;
          5. Current or past oncological diagnosis&#xD;
&#xD;
          6. Other serious medical conditions (meningitis, encephalitis, stroke)&#xD;
&#xD;
          7. Acute otitis media&#xD;
&#xD;
          8. Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)&#xD;
&#xD;
          9. Pregnancy or breastfeeding&#xD;
&#xD;
         10. Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms&#xD;
&#xD;
         11. Immunization with live vaccine 1 month prior onset of symptoms&#xD;
&#xD;
         12. Requirement of live vaccine within 2 months from start of experimental treatment&#xD;
             (prednisolone or placebo)&#xD;
&#xD;
         13. Evaluation of primary endpoint at 12 months not feasible for any reason&#xD;
&#xD;
         14. Previously included into the FACE study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbro Hedin Skogman, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Center for Clinical Research Dalarna</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barbro Hedin Skogman, MD, PhD</last_name>
    <phone>+46 (0)23 49 20 00</phone>
    <email>barbro.hedinskogman@regiondalarna.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sofia Karlsson, MD</last_name>
    <phone>+46 (0)23 49 20 00</phone>
    <email>sofia.a.karlsson@regiondalarna.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Barn- och ungdomsmedicin</name>
      <address>
        <city>Falun</city>
        <state>Dalarna</state>
        <zip>79131</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbro Hedin Skogman</last_name>
      <phone>+46 (0)23 49 20 00</phone>
      <email>barbro.hedinskogman@regiondalarna.se</email>
    </contact>
    <investigator>
      <last_name>Barbro Hedin Skogman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn och ungdomskliniken, Länssjukhuset</name>
      <address>
        <city>Kalmar</city>
        <state>Region Kalmar</state>
        <zip>S-391 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Röcknert Tjernberg, PhD</last_name>
      <phone>+46(0)70-2370430</phone>
      <email>anna.rockert@regionkalmar.se</email>
    </contact>
    <investigator>
      <last_name>Anna Röcknert Tjernberg, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barnkliniken, Skaraborgs sjukhus</name>
      <address>
        <city>Skövde</city>
        <state>Västra Götalands Region</state>
        <zip>S-541 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carl Johan Törnhage, PhD</last_name>
      <phone>+46(0)76 250 76 15</phone>
      <email>carl-johan.tornhage@vgregion.se</email>
    </contact>
    <investigator>
      <last_name>Carl Johan Törnhage, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn- och ungdomskliniken</name>
      <address>
        <city>Borås</city>
        <zip>50555</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Athanasios Sousoulas</last_name>
      <phone>+46(0)33-6164739</phone>
      <email>Athanasios.Sousoulas@vgregion.se</email>
    </contact>
    <investigator>
      <last_name>Athanasios Sousoulas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn- och ungdomsmedicin</name>
      <address>
        <city>Helsingborg</city>
        <zip>75187</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Valeur</last_name>
      <phone>+46(0)42-4061603</phone>
      <email>Maria.Valeur@skane.se</email>
    </contact>
    <investigator>
      <last_name>Maria Valeur</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn- och ungdomsmedicinska kliniken</name>
      <address>
        <city>Jönköping</city>
        <zip>55185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thea Hamell</last_name>
      <phone>+46(0)10-2422000</phone>
      <email>Thea.Hamell@rjl.se</email>
    </contact>
    <investigator>
      <last_name>Thea Hamell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn- och ungdomsmottagning</name>
      <address>
        <city>Karlskrona</city>
        <zip>37185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mia Olsson Engman</last_name>
      <phone>+46(0)455-734253</phone>
      <email>Mia.Engman@regionblekinge.se</email>
    </contact>
    <investigator>
      <last_name>Mia Olsson Engman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn- och ungdomsmottagning</name>
      <address>
        <city>Kristianstad</city>
        <zip>29185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulrike Schmidt</last_name>
      <phone>+46(0)44-3092915</phone>
      <email>Ulrike.Schmidt@skane.se</email>
    </contact>
    <investigator>
      <last_name>Ulrike Schmidt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus</name>
      <address>
        <city>Linköping</city>
        <zip>58585</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Peter Wide</last_name>
      <phone>+46(0)10-1030000</phone>
      <email>Peter.Wide@regionostergotland.se</email>
    </contact>
    <investigator>
      <last_name>Peter Wide</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Akutmottagning för barn, Skåne Universitets sjukhus</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karin Stålhammar</last_name>
      <phone>+46(0)46-17 10 00</phone>
      <email>Karin.Stalhammar@skane.se</email>
    </contact>
    <investigator>
      <last_name>Karin Stålhammar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barnakuten i Malmö, Skåne Universitets sjukhus</name>
      <address>
        <city>Malmö</city>
        <zip>20502</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Karlsson</last_name>
      <phone>+46(0)40-33 10 00</phone>
      <email>Anna.v.Karlsson@skane.se</email>
    </contact>
    <investigator>
      <last_name>Anna Karlsson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn- och ungdomskliniken, Vrinnevi sjukhuset</name>
      <address>
        <city>Norrköping</city>
        <zip>S-601 82</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Nordwall</last_name>
      <phone>+46(0)10-103 00 00</phone>
      <email>Maria.Nordvall@regionostergotland.se</email>
    </contact>
    <investigator>
      <last_name>Maria Nordwall</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Astrid Lindgrens barnsjukhus, Karolinska Solna</name>
      <address>
        <city>Solna</city>
        <zip>71764</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sigurdur Arnason</last_name>
      <phone>+46(0)8-517 700 00</phone>
      <email>sigurdur.arnason@sll.se</email>
    </contact>
    <investigator>
      <last_name>Sigurdur Arnason</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sachsska barnsjukhuset</name>
      <address>
        <city>Stockholm</city>
        <zip>11883</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charlotta Nordenhäll</last_name>
      <phone>+46(0)8-616 40 00</phone>
      <email>charlotta.nordenhall@sll.se</email>
    </contact>
    <investigator>
      <last_name>Charlotta Nordenhäll</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Astrid Lindgrens barnsjukhus, Karolinska Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Åsa Fowler</last_name>
      <phone>+46(0)8-585 800 00</phone>
      <email>asa.fowler@sll.se</email>
    </contact>
    <investigator>
      <last_name>Åsa Fowler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Akademisk Barnsjukhuset</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Lundgren</last_name>
      <phone>+46(0)18-611 00 00</phone>
      <email>maria.lundgren@kbh.uu.se</email>
    </contact>
    <investigator>
      <last_name>Maria Lundgren</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn och ungdomsmedicin, Västmanlands sjukhus</name>
      <address>
        <city>Västerås</city>
        <zip>72189</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annika Gunnarsson, MD</last_name>
      <phone>+46 (0) 21-17 00 00</phone>
      <email>annika.gunnarsson@regionvastmanland.se</email>
    </contact>
    <investigator>
      <last_name>Annika Gunnarsson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Barn- och ungdomskliniken, Universitets sjukhuset Örebro</name>
      <address>
        <city>Örebro</city>
        <zip>S-70185</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nisse Sandlund</last_name>
      <phone>+46(0)19-602 10 00</phone>
      <email>nisse.sandlund@regionorebrolan.se</email>
    </contact>
    <investigator>
      <last_name>Nisse Sandlund</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalarna County Council, Sweden</investigator_affiliation>
    <investigator_full_name>Barbro Hedin Skogman</investigator_full_name>
    <investigator_title>MD, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Paediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bell Palsy</mesh_term>
    <mesh_term>Borrelia Infections</mesh_term>
    <mesh_term>Facial Paralysis</mesh_term>
    <mesh_term>Facial Nerve Diseases</mesh_term>
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Facies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03781700/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 20, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03781700/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03781700
org study id: FACE-01
secondary id: 2017-004187-35
nct id: NCT03781700
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these
      children will have persistent symptoms with excessive tear secretion, drooling and social
      problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with
      acute facial nerve palsy have shown beneficial effects, but no studies with strong quality
      have been performed in children.

      Investigators will perform a double-blind randomized placebo-controlled multicenter trial on
      children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12
      study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10
      days (or placebo) will be started on admission. Clinical data, including recovery will be
      followed-up until 12 months.

      The primary outcome is defined as total recovery of the facial nerve palsy, measured with the
      House-Brackmann scale (grade 1) at 12-months follow-up.

      The overall purpose is to assess the utility of cortisone treatment given to children with
      acute facial nerve palsy in this study. If the total recovery rate is significantly improved
      in the prednisolone group as compared to the placebo group, prednisolone treatment will be
      introduced in clinical practice for children with acute facial nerve palsy in order to reduce
      the risk of persistent symptoms.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: House-Brackmann scale
time frame: At 12 months (+/- 2 weeks) after inclusion
description: Total recovery in the two treatment groups measured with the House-Brackmann scale.
The House-Brackmann scale (I is normal function and VI is total loss of function) is chosen as primary outcome measure since it is an objective instrument, easy to perform and the one most frequently used in previous studies. The time point 12 months for evaluation of total recovery is chosen as no further improvement of the facial nerve function is expected after 12 months.
measure: Sunnybrook facial grading system
time frame: At 12 months (+/- 2 weeks) after inclusion
description: Total recovery in the two treatment groups measured with the Sunnybrook scale.
The Sunnybrook scale (100 is normal function and 0 is total loss of function) is another objective scale for grading the facial nerve function. It will be used as secondary outcome measure. It is easy to perform and has been used in previous studies in children. It correlates well to the House-Brackmann scale.
measure: Facial Disability Index (FDI)
time frame: At 12 months (+/- 2 weeks) after inclusion
description: Disease-specific Quality-of-Life assessment scale, with 5 functional domains (5 means no probelms and 2 or 1 means problems all the time) and 5 social domains (6 means problems all the time and 1 means no problems at all)
measure: Facial Clinimetric Evaluation (FaCE) Scale
time frame: At 12 months (+/- 2 weeks) after inclusion
description: Disease-specific Quality-of-Life assessment scale, with 15 functional and social domains (1 means problems all the time and 5 means no problems at all).
measure: Synkinesis Assessment Questionnaire (SAQ)
time frame: At 12 month (+/- 2 weeks) after inclusion
description: Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).
measure: Adverse events
time frame: Up to 12 month (+/- 2 weeks) after inclusion
description: Number of Adverse Events possibly or probably related to the study drug.
arm group label: Prednisolone
arm group type: Experimental
description: Prednisolone
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo oral tablet
intervention type: Drug
intervention name: Prednisolone
description: Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
arm group label: Prednisolone
other name: Batch 18A71, Orifarm Generics A/S
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo tablets with identical appearance to the experimental drug
arm group label: Placebo
other name: Batch 18A61, Orifarm Generics A/S
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: No
last name: Barbro Hedin Skogman, MD, PhD
role: Study Director
affiliation: Center for Clinical Research Dalarna
last name: Barbro Hedin Skogman, MD, PhD
phone: +46 (0)23 49 20 00
email: barbro.hedinskogman@regiondalarna.se
last name: Sofia Karlsson, MD
phone: +46 (0)23 49 20 00
email: sofia.a.karlsson@regiondalarna.se
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status: Recruiting
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country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Dalarna County Council, Sweden
investigator full name: Barbro Hedin Skogman
investigator title: MD, Assistant Professor
mesh term: Bell Palsy
mesh term: Borrelia Infections
mesh term: Facial Paralysis
mesh term: Facial Nerve Diseases
mesh term: Paralysis
mesh term: Nervous System Diseases
mesh term: Facies
mesh term: Prednisolone
sharing ipd: No
provided document: 
provided document: 