Evaluation of cortisone treatment in children suffering from acute facial nerve paralysis.
- Conditions
- Facial Nerve Palsy (Bells Palsy)MedDRA version: 21.0Level: LLTClassification code: 10077335Term: Facial nerve paresis Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-513430-37-00
- Lead Sponsor
- Region Dalarna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1-17 years of age, Acute peripheral facial nerve palsy, Less than 72 hours of duration of symptoms, Signed informed consent.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method