Facial Nerve Palsy (Bells Palsy)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPlacebo capsules corresponding to Prednisolone 5 mg for oral administration.
DRUGPREDNISOLONE
Sponsors
Region Dalarna
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Sweden
Outcome results
None listed