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

Dalarna County Council, Sweden

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Placebo Oral Tablet; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03781700

FACE-01

2017-004187-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups, including a placebo group

Prednisolone

Experimental group

Description:

Prednisolone

Treatment:

Drug: Prednisolone

Placebo

Placebo Comparator group

Description:

Placebo oral tablet

Treatment:

Drug: Placebo Oral Tablet