Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy (FACE)
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|ClinicalTrials.gov Identifier: NCT03781700|
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : May 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Facial Palsy Facial Nerve Diseases Borrelia Infection of Central Nervous System Bell Palsy||Drug: Prednisolone Drug: Placebo Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial|
|Actual Study Start Date :||May 3, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2026|
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
Other Name: Batch 18A71, Orifarm Generics A/S
Placebo Comparator: Placebo
Placebo oral tablet
Drug: Placebo Oral Tablet
Placebo tablets with identical appearance to the experimental drug
Other Name: Batch 18A61, Orifarm Generics A/S
- House-Brackmann scale [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]
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.
- Sunnybrook facial grading system [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]
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.
- Facial Disability Index (FDI) [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]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)
- Facial Clinimetric Evaluation (FaCE) Scale [ Time Frame: At 12 months (+/- 2 weeks) after inclusion ]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).
- Synkinesis Assessment Questionnaire (SAQ) [ Time Frame: At 12 month (+/- 2 weeks) after inclusion ]Subjective grading of synkinesis symptoms with 9 functional domains (1 means no problems at all and 5 means problems all the time).
- Adverse events [ Time Frame: Up to 12 month (+/- 2 weeks) after inclusion ]Number of Adverse Events possibly or probably related to the study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781700
|Contact: Barbro Hedin Skogman, MD, PhD||+46 (0)23 49 20 email@example.com|
|Contact: Sofia Karlsson, MD||+46 (0)23 49 20 firstname.lastname@example.org|
|Barn- och ungdomsmedicin||Recruiting|
|Falun, Dalarna, Sweden, 79131|
|Contact: Barbro Hedin Skogman +46 (0)23 49 20 00 email@example.com|
|Principal Investigator: Barbro Hedin Skogman|
|Akutmottagning för barn||Recruiting|
|Lund, Sweden, 22185|
|Contact: Veronika Chytilová +46(0)46-17 10 00 Veronika.Chytilova@skane.se|
|Principal Investigator: Veronika Chytilová|
|Malmö, Sweden, 20502|
|Contact: Karin Stålhammar +46(0)40-33 10 00 Karin.Stalhammar@skane.se|
|Principal Investigator: Karin Stålhammar|
|Barn- och ungdomskliniken||Recruiting|
|Norrköping, Sweden, 60379|
|Contact: Maria Nordwall +46(0)10-103 00 00 Maria.Nordvall@regionostergotland.se|
|Principal Investigator: Maria Nordwall|
|Astrid Lindgrens barnsjukhus, Karolinska Solna||Recruiting|
|Solna, Sweden, 71764|
|Contact: Sigurdur Arnason +46(0)8-517 700 00 firstname.lastname@example.org|
|Principal Investigator: Sigurdur Arnason|
|Stockholm, Sweden, 11883|
|Contact: Charlotta Nordenhäll +46(0)8-616 40 00 email@example.com|
|Principal Investigator: Charlotta Nordenhäll|
|Astrid Lindgrens barnsjukhus, Karolinska Huddinge||Recruiting|
|Stockholm, Sweden, 14186|
|Contact: Åsa Fowler +46(0)8-585 800 00 firstname.lastname@example.org|
|Principal Investigator: Åsa Fowler|
|Uppsala, Sweden, 75185|
|Contact: Maria Lundgren +46(0)18-611 00 00 email@example.com|
|Principal Investigator: Maria Lundgren|
|Barn och ungdomsmedicin||Recruiting|
|Västerås, Sweden, 72189|
|Contact: Annika Gunnarsson, MD +46 (0) 21-17 00 00 firstname.lastname@example.org|
|Principal Investigator: Annika Gunnarsson|
|Barn- och ungdomskliniken||Recruiting|
|Örebro, Sweden, 70185|
|Contact: Nisse Sandlund +46(0)19-602 10 00 email@example.com|
|Principal Investigator: Nisse Sandlund|
|Study Director:||Barbro Hedin Skogman, MD, PhD||Center for Clinical Research Dalarna|