A Phase 4 interventional study of Prednisolone and Placebo Oral Tablet in Facial Palsy, Facial Nerve Diseases and Borrelia Infection of Central Nervous System, sponsored by Dalarna County Council, Sweden. Completed at 15 sites in Sweden. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Dalarna County Council, Sweden · Phase 4, Interventional, and Treatment
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.
81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.
This study's enrollment of 343 is above the median of 50 across 59 interventional studies indexed under Facial Paralysis.
Browse Facial Paralysis studies →Dalarna County Council, Sweden is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prednisolone
Drug: Prednisolone
Placebo oral tablet
Drug: Placebo Oral Tablet
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
Also known as: Batch 18A71, Orifarm Generics A/S
Placebo tablets with identical appearance to the experimental drug
Also known as: Batch 18A61, Orifarm Generics A/S
House-Brackmann scale
Total recovery in the two treatment groups measured with the House-Brackmann scale. The House-Brackmann scale (I is normal function and VI is total loss of function) is chosen as primary outcome measure since it is an objective instrument, easy to perform and the one most frequently used in previous studies. The time point 12 months for evaluation of total recovery is chosen as no further improvement of the facial nerve function is expected after 12 months.
Time frame: At 12 months (+/- 2 weeks) after inclusion
Sunnybrook facial grading system
Total recovery in the two treatment groups measured with the Sunnybrook scale. The Sunnybrook scale (100 is normal function and 0 is total loss of function) is another objective scale for grading the facial nerve function. It will be used as secondary outcome measure. It is easy to perform and has been used in previous studies in children. It correlates well to the House-Brackmann scale.
Time frame: At 12 months (+/- 2 weeks) after inclusion
Facial Disability Index (FDI)
Disease-specific Quality-of-Life assessment scale, with 5 functional domains (5 means no probelms and 2 or 1 means problems all the time) and 5 social domains (6 means problems all the time and 1 means no problems at all)
Time frame: At 12 months (+/- 2 weeks) after inclusion
Facial Clinimetric Evaluation (FaCE) Scale
Disease-specific Quality-of-Life assessment scale, with 15 functional and social domains (1 means problems all the time and 5 means no problems at all).
Time frame: At 12 months (+/- 2 weeks) after inclusion
Synkinesis Assessment Questionnaire (SAQ)
Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).
Time frame: At 12 month (+/- 2 weeks) after inclusion
Adverse events
Number of Adverse Events possibly or probably related to the study drug.
Time frame: Up to 12 month (+/- 2 weeks) after inclusion
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Aug 2026, 87 months.
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Studies of the drug tested here: Prednisolone
Dalarna County Council, Sweden