Bell's Palsy in Children: A Multi-centre, double-blind, Randomised, Placebo-controlled Trial to Determine Whether Prednisolone Improves Recovery at 1 Month.

Phase 3

Recruiting

• Conditions: Bell's Palsy; Neurological - Other neurological disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12615000563561
• Lead Sponsor: Franz Babl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-01
• Last Update Posted: 16 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Patients must be aged between 6 months to less than 18 years, weigh greater than or equal to 5kg, be diagnosed with Bell's Palsy by their treating doctor and have an acute onset of symptoms of Bell's palsy for less than 72 hours prior to randomisation

Exclusion Criteria

- Previous episode of Bell's Palsy or previously randomised in BellPIC study
- Contraindication to prednisolone: active or latent tuberculosis, systemic fungal infection, known hypersensitivity to prednisolone, diminished cardiac function, diabetes mellitus, peptic ulcer or chronic renal function, multiple sclerosis or recent active herpes zoster or chickenpox
- current use of systemic or inhaled steroid, or use within 2 weeks prior to the onset symptoms
- current or past oncological diagnosis
- FBE result (if obtained during this illness) may indicate leukaemia
- Pregnancy and/or lactating
- Currently receiving medications for which prednisolone is contraindicated
- Immunisation with a live vaccine within the previous 1 month
- Requirement for live vaccine within 6 weeks of first dose of prednisolone
- Signs of upper motor neuron VII nerve palsy (weakness of lower half of the face only)
- Current or recent (1 week prior to Bell's palsy symptoms) otitis media
- Evidence of vesicles on the ear from or vesicles/ulcers elsewhere on the body suggestive of recent herpes simplex, herpes zoster or chickenpox
- Known significant facial trauma within 1 week prior to symptoms appearing
- Referred to GP clinic in Emergency Department or failed to wait
- Unable to attend a follow up visit in one month time
- Any other condition at risk of being influenced by study treatment or completion of study
- Parents will not be able to comply with the study, or have enough understanding of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is complete recovery at one month post randomisation, where recovery is defined as a House Brackmann facial grading score of 1. Recovery will be assesed by a specialist clinician in a face to face setting[One month post randomisation]