Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
NCT ID: NCT03781700
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
500 participants
INTERVENTIONAL
2019-05-03
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Prednisolone
Prednisolone
Prednisolone
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
Placebo
Placebo oral tablet
Placebo Oral Tablet
Placebo tablets with identical appearance to the experimental drug
Interventions
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Prednisolone
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
Placebo Oral Tablet
Placebo tablets with identical appearance to the experimental drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Acute peripheral unilateral facial nerve palsy
3. Less than 72 hours since debut of symptoms
4. Signed informed consent
Exclusion Criteria
2. Central or bilateral facial nerve palsy
3. Malformations in head and neck
4. Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, 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
1 Year
17 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Dalarna County Council, Sweden
OTHER
Responsible Party
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Barbro Hedin Skogman
MD, Assistant Professor
Principal Investigators
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Barbro Hedin Skogman, MD, PhD
Role: STUDY_DIRECTOR
Center for Clinical Research Dalarna
Locations
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Barn- och ungdomsmedicin
Falun, Dalarna County, Sweden
Barn och ungdomskliniken, Länssjukhuset
Kalmar, Region Kalmar, Sweden
Barnkliniken, Skaraborgs sjukhus
Skövde, Västra Götalands Region, Sweden
Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset
Gothenburg, , Sweden
Barn- och ungdomsmedicinska kliniken
Jönköping, , Sweden
Barn- och ungdomsmottagning
Karlskrona, , Sweden
HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus
Linköping, , Sweden
Akutmottagning för barn, Skåne Universitets sjukhus
Lund, , Sweden
Barnakuten i Malmö, Skåne Universitets sjukhus
Malmo, , Sweden
Barn- och ungdomskliniken, Vrinnevi sjukhuset
Norrköping, , Sweden
Barn- och ungdomskliniken, Universitets sjukhuset Örebro
Örebro, , Sweden
Astrid Lindgrens barnsjukhus, Karolinska Solna
Solna, , Sweden
Sachsska barnsjukhuset
Stockholm, , Sweden
Astrid Lindgrens barnsjukhus, Karolinska Huddinge
Stockholm, , Sweden
Akademisk Barnsjukhuset
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Katarina Adrian
Role: primary
Åsa Laestadius
Role: primary
References
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Karlsson S, Arnason S, Hadziosmanovic N, Laestadius A, Hultcrantz M, Marsk E, Skogman BH. The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area. BMC Pediatr. 2021 May 4;21(1):220. doi: 10.1186/s12887-021-02571-w.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004187-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FACE-01
Identifier Type: -
Identifier Source: org_study_id
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