Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Study Overview
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Brief Summary
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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.

Official Title
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The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial

Conditions
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Facial Palsy, Facial Nerve Diseases, Borrelia Infection of Central Nervous System, Bell Palsy

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-17 years of age Acute peripheral unilateral facial nerve palsy Less than 72 hours since debut of symptoms Signed informed consent Exclusion Criteria: Head trauma <1 month Central or bilateral facial nerve palsy Malformations in head and neck Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose) Current or past oncological diagnosis Other serious medical conditions (meningitis, encephalitis, stroke) Acute otitis media Signs of herpes simplex or varicella zoster infection (vesicles in the ear region) Pregnancy or breastfeeding Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms Immunization with live vaccine 1 month prior onset of symptoms Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo) Evaluation of primary endpoint at 12 months not feasible for any reason Previously included into the FACE study

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone<br>Prednisolone | Drug: Prednisolone<br>* Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.<br>* Other names: Batch 18A71, Orifarm Generics A/S;|
| Placebo Comparator: Placebo<br>Placebo oral tablet | Drug: Placebo Oral Tablet<br>* Placebo tablets with identical appearance to the experimental drug<br>* Other names: Batch 18A61, Orifarm Generics A/S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| House-Brackmann scale | 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. | At 12 months (+/- 2 weeks) after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sunnybrook facial grading system | 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. | At 12 months (+/- 2 weeks) after inclusion | 
| Facial Disability Index (FDI) | 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) | At 12 months (+/- 2 weeks) after inclusion | 
| Facial Clinimetric Evaluation (FaCE) Scale | 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). | At 12 months (+/- 2 weeks) after inclusion | 
| Synkinesis Assessment Questionnaire (SAQ) | Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time). | At 12 month (+/- 2 weeks) after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Paediatric