NCT03781700 Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
| NCT ID | NCT03781700 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dalarna County Council, Sweden |
| Condition | Facial Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2019-05-03 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2019-05-03 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 1-17 years of age 2. Acute peripheral unilateral facial nerve palsy 3. Less than 72 hours since debut of symptoms 4. Signed informed consent Exclusion Criteria: 1. Head trauma \<1 month 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
Contact & Investigator
Barbro Hedin Skogman, MD, PhD
STUDY DIRECTOR
Center for Clinical Research Dalarna
Frequently Asked Questions
Who can join the NCT03781700 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Facial Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03781700 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03781700 currently recruiting?
Yes, NCT03781700 is actively recruiting participants. Contact the research team at barbro.hedinskogman@regiondalarna.se for enrollment information.
Where is the NCT03781700 trial being conducted?
This trial is being conducted at Falun, Sweden, Kalmar, Sweden, Skövde, Sweden, Gothenburg, Sweden and 11 additional locations.
Who is sponsoring the NCT03781700 clinical trial?
NCT03781700 is sponsored by Dalarna County Council, Sweden. The principal investigator is Barbro Hedin Skogman, MD, PhD at Center for Clinical Research Dalarna. The trial plans to enroll 500 participants.
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