Facial Nerve Palsy (Bells Palsy) MedDRA version: 21.0 Level: LLT Classification code 10077335 Term: Facial nerve paresis System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Prednisolon
Product Name: Prednisolon
Pharmaceutical Form: Capsule
INN or Proposed INN: Prednisolon
CAS Number: 50-24-8
Other descriptive name: PREDNISOLONE
Concentration unit: mg millig
Sponsors
Falun Hospital
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: 1. Trauma 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of cortisone versus placebo treatment in children with acute facial nerve palsy, measured as total recovery with the House-Brackmann scale at 12 months follow-up.;Secondary Objective: To evaluate the efficacy of cortisone versus placebo treatment in children with acute facial nerve palsy measured as total recovery with the Sunnybrook scale at 12 months follow-up. To evaluate the total recovery rate with both Sunnybrook and House-Brackmann scale at 1 month as compared to the total recovery rate at 12 months, in order to evaluate if prediction of recovery at 1 month is feasible and/or useful in children with acute facial nerve palsy. To evaluate subjective symptoms and influence in daily life with the Facial Clinimetric Evaluation (FaCE) scale, the Facial Disability Index (FDI) and the Synkinesis Assessment Questionnaire (SAQ) at 1 and 12 months follow-up. To evaluate the safety profile for cortisone in children suffering from acute facial nerve palsy. ;Primary end point(s): Primary endpoint is the number of patients with total recovery of the facial nerve palsy measured by the House-Brackmann grading scale at 12 months follow-up. This is chosen to be a robust primary endpoint which has also been used in previous studies in pediatric and adult patients. ;Timepoint(s) of evaluation of this end point: 12 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The total number of patients with total recovery, measured by the Sunnybrook grading scale at 12 months follow-up, in the two subgroups of patients with idiopathic or Borrelia associated facial nerve palsy. The total recovery rate with both Sunnybrook and House-Brakmann scales at 1 month compared to 12 months. Subjective symptoms and influence in Daily Life with the Facial Clinimetric Evaluation (FaCE) scale, the Facial Disability Index (FDI) and the Synkinesis Assessment Questionnaire (SAQ) at 1 and 12 months follow-up. Safety profile by adverse event reporting.;Timepoint(s) of evaluation of this end point: One and twelve months follow-up. | — |
Countries
Sweden
Contacts
Public ContactBarn och ungdomsmedicin
Falun Hospital
Outcome results
None listed