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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

  • 1-17 years of age
  • Acute peripheral unilateral facial nerve palsy
  • Less than 72 hours since debut of symptoms
  • Signed informed consent

Exclusion

  • 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

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)

Enter a location and click search to find clinical trials sorted by distance.

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