Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

NCT03781700 | Recruiting Phase 4 DMC

• 2 other identifiers: FACE-012017-004187-35
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 15

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.

Conditions

Facial Palsy; Facial Nerve Diseases; Borrelia Infection of Central Nervous System; Bell Palsy

Keywords

Children; Paediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sunnybrook facial grading system

  At 12 months (+/- 2 weeks) after inclusion

• Facial Disability Index (FDI)

  At 12 months (+/- 2 weeks) after inclusion

• Facial Clinimetric Evaluation (FaCE) Scale

  At 12 months (+/- 2 weeks) after inclusion

• Synkinesis Assessment Questionnaire (SAQ)

  At 12 month (+/- 2 weeks) after inclusion

Other Outcomes (1)

• Adverse events

  Up to 12 month (+/- 2 weeks) after inclusion

Study Arms (2)

Prednisolone

EXPERIMENTAL

Prednisolone

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Placebo oral tablet

Drug: Placebo Oral Tablet

Interventions

Prednisolone DRUG

Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.

Also known as: Batch 18A71, Orifarm Generics A/S

Prednisolone

Placebo Oral Tablet DRUG

Placebo tablets with identical appearance to the experimental drug

Also known as: Batch 18A61, Orifarm Generics A/S

Placebo

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• Acute peripheral unilateral facial nerve palsy
• Less than 72 hours since debut of symptoms
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead
• Karolinska Institutet: collaborator

Study Sites (15)

Barn- och ungdomsmedicin

Falun, Dalarna County, 79131, Sweden

RECRUITING

Barn och ungdomskliniken, Länssjukhuset

Kalmar, Region Kalmar, S-391 85, Sweden

RECRUITING

Barnkliniken, Skaraborgs sjukhus

Skövde, Västra Götalands Region, S-541 85, Sweden

RECRUITING

Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset

Gothenburg, Sweden

RECRUITING

Barn- och ungdomsmedicinska kliniken

Jönköping, 55185, Sweden

RECRUITING

Barn- och ungdomsmottagning

Karlskrona, 37185, Sweden

RECRUITING

HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus

Linköping, 58585, Sweden

RECRUITING

Akutmottagning för barn, Skåne Universitets sjukhus

Lund, 22185, Sweden

RECRUITING

Barnakuten i Malmö, Skåne Universitets sjukhus

Malmo, 20502, Sweden

RECRUITING

Barn- och ungdomskliniken, Vrinnevi sjukhuset

Norrköping, S-601 82, Sweden

RECRUITING

Barn- och ungdomskliniken, Universitets sjukhuset Örebro

Örebro, S-70185, Sweden

RECRUITING

Astrid Lindgrens barnsjukhus, Karolinska Solna

Solna, 71764, Sweden

RECRUITING

Sachsska barnsjukhuset

Stockholm, 11883, Sweden

RECRUITING

Astrid Lindgrens barnsjukhus, Karolinska Huddinge

Stockholm, 14186, Sweden

RECRUITING

Akademisk Barnsjukhuset

Uppsala, 75185, Sweden

RECRUITING

Related Publications (1)

• Karlsson S, Arnason S, Hadziosmanovic N, Laestadius A, Hultcrantz M, Marsk E, Skogman BH. The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area. BMC Pediatr. 2021 May 4;21(1):220. doi: 10.1186/s12887-021-02571-w.

  PMID: 33947355 DERIVED

MeSH Terms

Conditions

Facial Paralysis; Facial Nerve Diseases; Bell Palsy

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cranial Nerve Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Barbro Hedin Skogman, MD, PhD

  Center for Clinical Research Dalarna

  STUDY DIRECTOR

Central Study Contacts

Barbro Hedin Skogman, MD, PhD

CONTACT

+46 (0)23 49 20 00; barbro.hedinskogman@regiondalarna.se

Sofia Karlsson, MD

CONTACT

+46 (0)23 49 20 00; sofia.a.karlsson@regiondalarna.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 20, 2018
• Study Start: May 3, 2019
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (15)