CTIS2024-513430-37-00RecruitingPhase 1
The FACE (Facial nerve palsy And Cortisone Evaluation) study in children: a randomised double-blind, placebo-controlled, multicenter trial. - FACE-01
Region Dalarna0 sitesStarted: May 16, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 17 (—)
- Sex
- All
Inclusion Criteria
- •1-17 years of age, Acute peripheral facial nerve palsy, Less than 72 hours of duration of symptoms, Signed informed consent.
Exclusion Criteria
- •Trauma, 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, Central facial nerve palsy, Malformations in head and neck, Conditions not compatible with cortisone treatment (hypertension, diabetes mellitus type 1, 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
Investigators
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