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

Sponsor
Dalarna County Council, Sweden (Other)
Overall Status
Recruiting
CT.gov ID
NCT03781700
Collaborator
Karolinska Institutet (Other)
500
18
2
92
27.8
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial
Actual Study Start Date :
May 3, 2019
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prednisolone

Prednisolone

Drug: Prednisolone
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
Other Names:
  • Batch 18A71, Orifarm Generics A/S
  • Placebo Comparator: Placebo

    Placebo oral tablet

    Drug: Placebo Oral Tablet
    Placebo tablets with identical appearance to the experimental drug
    Other Names:
  • Batch 18A61, Orifarm Generics A/S
  • Outcome Measures

    Primary Outcome Measures

    1. House-Brackmann scale [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.

    Secondary Outcome Measures

    1. Sunnybrook facial grading system [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.

    2. Facial Disability Index (FDI) [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)

    3. Facial Clinimetric Evaluation (FaCE) Scale [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).

    4. Synkinesis Assessment Questionnaire (SAQ) [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).

    Other Outcome Measures

    1. Adverse events [Up to 12 month (+/- 2 weeks) after inclusion]

      Number of Adverse Events possibly or probably related to the study drug.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barn- och ungdomsmedicin Falun Dalarna Sweden 79131
    2 Barn och ungdomskliniken, Länssjukhuset Kalmar Region Kalmar Sweden S-391 85
    3 Barnkliniken, Skaraborgs sjukhus Skövde Västra Götalands Region Sweden S-541 85
    4 Barn- och ungdomskliniken Borås Sweden 50555
    5 Barn- och ungdomsmedicin Helsingborg Sweden 75187
    6 Barn- och ungdomsmedicinska kliniken Jönköping Sweden 55185
    7 Barn- och ungdomsmottagning Karlskrona Sweden 37185
    8 Barn- och ungdomsmottagning Kristianstad Sweden 29185
    9 HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus Linköping Sweden 58585
    10 Akutmottagning för barn, Skåne Universitets sjukhus Lund Sweden 22185
    11 Barnakuten i Malmö, Skåne Universitets sjukhus Malmö Sweden 20502
    12 Barn- och ungdomskliniken, Vrinnevi sjukhuset Norrköping Sweden S-601 82
    13 Astrid Lindgrens barnsjukhus, Karolinska Solna Solna Sweden 71764
    14 Sachsska barnsjukhuset Stockholm Sweden 11883
    15 Astrid Lindgrens barnsjukhus, Karolinska Huddinge Stockholm Sweden 14186
    16 Akademisk Barnsjukhuset Uppsala Sweden 75185
    17 Barn och ungdomsmedicin, Västmanlands sjukhus Västerås Sweden 72189
    18 Barn- och ungdomskliniken, Universitets sjukhuset Örebro Örebro Sweden S-70185

    Sponsors and Collaborators

    • Dalarna County Council, Sweden
    • Karolinska Institutet

    Investigators

    • Study Director: Barbro Hedin Skogman, MD, PhD, Center for Clinical Research Dalarna

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Barbro Hedin Skogman, MD, Assistant Professor, Dalarna County Council, Sweden
    ClinicalTrials.gov Identifier:
    NCT03781700
    Other Study ID Numbers:
    • FACE-01
    • 2017-004187-35
    First Posted:
    Dec 20, 2018
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Barbro Hedin Skogman, MD, Assistant Professor, Dalarna County Council, Sweden
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 27, 2021