The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial

Who is this study for? Pediatric patients age 1 to 17 years with facial nerve palsy including Bell's palsy and palsy from Lyme disease
What treatments are being studied? Prednisolone
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children. Investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12 study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. Clinical data, including recovery will be followed-up until 12 months. The primary outcome is defined as total recovery of the facial nerve palsy, measured with the House-Brackmann scale (grade 1) at 12-months follow-up. The overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. If the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• 1-17 years of age

• Acute peripheral unilateral facial nerve palsy

• Less than 72 hours since debut of symptoms

• Signed informed consent

Locations
Other Locations
Sweden
Barn- och ungdomsmedicin
RECRUITING
Falun
Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
RECRUITING
Gothenburg
Barn- och ungdomsmedicinska kliniken
RECRUITING
Jönköping
Barn och ungdomskliniken, Länssjukhuset
RECRUITING
Kalmar
Barn- och ungdomsmottagning
RECRUITING
Karlskrona
HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
RECRUITING
Linköping
Akutmottagning för barn, Skåne Universitets sjukhus
RECRUITING
Lund
Barnakuten i Malmö, Skåne Universitets sjukhus
RECRUITING
Malmo
Barn- och ungdomskliniken, Vrinnevi sjukhuset
RECRUITING
Norrköping
Barn- och ungdomskliniken, Universitets sjukhuset Örebro
RECRUITING
Örebro
Barnkliniken, Skaraborgs sjukhus
RECRUITING
Skövde
Astrid Lindgrens barnsjukhus, Karolinska Solna
RECRUITING
Solna
Astrid Lindgrens barnsjukhus, Karolinska Huddinge
RECRUITING
Stockholm
Sachsska barnsjukhuset
RECRUITING
Stockholm
Akademisk Barnsjukhuset
RECRUITING
Uppsala
Contact Information
Primary
Barbro Hedin Skogman, MD, PhD
barbro.hedinskogman@regiondalarna.se
+46 (0)23 49 20 00
Backup
Sofia Karlsson, MD
sofia.a.karlsson@regiondalarna.se
+46 (0)23 49 20 00
Time Frame
Start Date: 2019-05-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 500
Treatments
Experimental: Prednisolone
Prednisolone
Placebo_comparator: Placebo
Placebo oral tablet
Authors
Annika Gunnarsson
Related Therapeutic Areas
Sponsors
Leads: Dalarna County Council, Sweden
Collaborators: Karolinska Institutet

This content was sourced from clinicaltrials.gov