Status:

RECRUITING

Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy

Lead Sponsor:

Dalarna County Council, Sweden

Collaborating Sponsors:

Karolinska Institutet

Conditions:

Facial Palsy

Facial Nerve Diseases

Eligibility:

All Genders

1-17 years

Phase:

PHASE4

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 a...

Eligibility Criteria

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

Key Trial Info

Start Date :

May 3 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT03781700

Start Date

May 3 2019

End Date

December 31 2026

Last Update

February 21 2025

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Barn- och ungdomsmedicin

Falun, Dalarna County, 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

Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset

Gothenburg, Sweden