EUCTR2017-004187-35-SE
Active, not recruiting
Phase 1
The FACE (Facial nerve palsy And Cortisone Evaluation) study in children: a randomised double-blind, placebo-controlled, multicenter trial.
Falun Hospital0 sites500 target enrollmentOctober 31, 2018
DrugsPrednisolon
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Falun Hospital
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.1\-17 years of age
- •2\.Acute peripheral facial nerve palsy
- •3\.Less than 72 hours of duration of symptoms
- •4\.Signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 500
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •2\.Central facial nerve palsy
- •3\.Malformations in head and neck
- •4\.Conditions not compatible with cortisone treatment (hypertension, diabetes mellitus type 1, 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
Outcomes
Primary Outcomes
Not specified
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