Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Bell Palsy Clinical Trial

— FACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781700
• Other study ID #: FACE-01
• Secondary ID: 2017-004187-35
• Status: Recruiting
• Phase: Phase 4
• Start date: May 3, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Dalarna County Council, Sweden
• Contact: Barbro Hedin Skogman, MD, PhD
• Phone: +46 (0)23 49 20 00
• Email: barbro.hedinskogman[@]regiondalarna.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Borrelia Infection of Central Nervous System
• Facial Nerve Diseases
• Facial Palsy
• Facial Paralysis
• Facies
• Nervous System Diseases
• Paralysis

Intervention

Drug:
• Prednisolone
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
• Placebo Oral Tablet
Placebo tablets with identical appearance to the experimental drug

Locations

Country	Name	City	State
Sweden	Barn- och ungdomsmedicin	Falun	Dalarna
Sweden	Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset	Göteborg
Sweden	Barn- och ungdomsmedicinska kliniken	Jönköping
Sweden	Barn och ungdomskliniken, Länssjukhuset	Kalmar	Region Kalmar
Sweden	Barn- och ungdomsmottagning	Karlskrona
Sweden	HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus	Linköping
Sweden	Akutmottagning för barn, Skåne Universitets sjukhus	Lund
Sweden	Barnakuten i Malmö, Skåne Universitets sjukhus	Malmö
Sweden	Barn- och ungdomskliniken, Vrinnevi sjukhuset	Norrköping
Sweden	Barn- och ungdomskliniken, Universitets sjukhuset Örebro	Örebro
Sweden	Barnkliniken, Skaraborgs sjukhus	Skövde	Västra Götalands Region
Sweden	Astrid Lindgrens barnsjukhus, Karolinska Solna	Solna
Sweden	Astrid Lindgrens barnsjukhus, Karolinska Huddinge	Stockholm
Sweden	Sachsska barnsjukhuset	Stockholm
Sweden	Akademisk Barnsjukhuset	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Dalarna County Council, Sweden	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Number of Adverse Events possibly or probably related to the study drug.	Up to 12 month (+/- 2 weeks) after inclusion
Primary	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	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
Secondary	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
Secondary	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
Secondary	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