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Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy (FACE)

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ClinicalTrials.gov Identifier: NCT03781700
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Barbro Hedin Skogman, Dalarna County Council, Sweden

Tracking Information
First Submitted Date  ICMJE December 14, 2018
First Posted Date  ICMJE December 20, 2018
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE May 3, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
House-Brackmann scale [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03781700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • Sunnybrook facial grading system [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]
    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.
  • Facial Disability Index (FDI) [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]
    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)
  • Facial Clinimetric Evaluation (FaCE) Scale [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]
    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).
  • Synkinesis Assessment Questionnaire (SAQ) [ Time Frame: At 12 month (+/- 2 weeks) after inclusion ]
    Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 17, 2018)
Adverse events [ Time Frame: Up to 12 month (+/- 2 weeks) after inclusion ]
Number of Adverse Events possibly or probably related to the study drug.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
Official Title  ICMJE The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Facial Palsy
  • Facial Nerve Diseases
  • Borrelia Infection of Central Nervous System
  • Bell Palsy
Intervention  ICMJE
  • Drug: Prednisolone
    Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
    Other Name: Batch 18A71, Orifarm Generics A/S
  • Drug: Placebo Oral Tablet
    Placebo tablets with identical appearance to the experimental drug
    Other Name: Batch 18A61, Orifarm Generics A/S
Study Arms  ICMJE
  • Experimental: Prednisolone
    Prednisolone
    Intervention: Drug: Prednisolone
  • Placebo Comparator: Placebo
    Placebo oral tablet
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 17, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 1-17 years of age
  2. Acute peripheral unilateral facial nerve palsy
  3. Less than 72 hours since debut of symptoms
  4. Signed informed consent

Exclusion Criteria:

  1. Head trauma <1 month
  2. Central or bilateral facial nerve palsy
  3. Malformations in head and neck
  4. Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
  5. Current or past oncological diagnosis
  6. Other serious medical conditions (meningitis, encephalitis, stroke)
  7. Acute otitis media
  8. Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
  9. Pregnancy or breastfeeding
  10. Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
  11. Immunization with live vaccine 1 month prior onset of symptoms
  12. Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
  13. Evaluation of primary endpoint at 12 months not feasible for any reason
  14. Previously included into the FACE study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barbro Hedin Skogman, MD, PhD +46 (0)23 49 20 00 barbro.hedinskogman@ltdalarna.se
Contact: Sofia Karlsson, MD +46 (0)23 49 20 00 sofia.a.karlsson@ltdalarna.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03781700
Other Study ID Numbers  ICMJE FACE-01
2017-004187-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barbro Hedin Skogman, Dalarna County Council, Sweden
Study Sponsor  ICMJE Dalarna County Council, Sweden
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE
Study Director: Barbro Hedin Skogman, MD, PhD Center for Clinical Research Dalarna
PRS Account Dalarna County Council, Sweden
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP