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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
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Barbro Hedin Skogman, Dalarna County Council, Sweden

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Prednisolone
Prednisolone
Drug: Prednisolone
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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)

  3. 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).

  4. 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).


Other Outcome Measures:
  1. Adverse events [ Time Frame: Up to 12 month (+/- 2 weeks) after inclusion ]
    Number of Adverse Events possibly or probably related to the study drug.



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Barbro Hedin Skogman, MD, PhD +46 (0)23 49 20 00 barbro.hedinskogman@ltdalarna.se
Contact: Sofia Karlsson, MD +46 (0)23 49 20 00 sofia.a.karlsson@ltdalarna.se

Locations
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Sweden
Barn- och ungdomsmedicin Recruiting
Falun, Dalarna, Sweden, 79131
Contact: Barbro Hedin Skogman    +46 (0)23 49 20 00    barbro.hedinskogman@ltdalarna.se   
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         
Barnakuten Recruiting
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    sigurdur.arnason@sll.se   
Principal Investigator: Sigurdur Arnason         
Sachsska barnsjukhuset Recruiting
Stockholm, Sweden, 11883
Contact: Charlotta Nordenhäll    +46(0)8-616 40 00    charlotta.nordenhall@sll.se   
Principal Investigator: Charlotta Nordenhäll         
Astrid Lindgrens barnsjukhus, Karolinska Huddinge Recruiting
Stockholm, Sweden, 14186
Contact: Åsa Fowler    +46(0)8-585 800 00    asa.fowler@sll.se   
Principal Investigator: Åsa Fowler         
Akademisk Barnsjukhuset Recruiting
Uppsala, Sweden, 75185
Contact: Maria Lundgren    +46(0)18-611 00 00    maria.lundgren@kbh.uu.se   
Principal Investigator: Maria Lundgren         
Barn och ungdomsmedicin Recruiting
Västerås, Sweden, 72189
Contact: Annika Gunnarsson, MD    +46 (0) 21-17 00 00    annika.gunnarsson@regionvastmanland.se   
Principal Investigator: Annika Gunnarsson         
Barn- och ungdomskliniken Recruiting
Örebro, Sweden, 70185
Contact: Nisse Sandlund    +46(0)19-602 10 00    nisse.sandlund@regionorebrolan.se   
Principal Investigator: Nisse Sandlund         
Sponsors and Collaborators
Dalarna County Council, Sweden
Karolinska Institutet
Investigators
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Study Director: Barbro Hedin Skogman, MD, PhD Center for Clinical Research Dalarna
  Study Documents (Full-Text)

Documents provided by Barbro Hedin Skogman, Dalarna County Council, Sweden:
Study Protocol  [PDF] November 30, 2018


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Responsible Party: Barbro Hedin Skogman, MD, Assistant Professor, Dalarna County Council, Sweden
ClinicalTrials.gov Identifier: NCT03781700     History of Changes
Other Study ID Numbers: FACE-01
2017-004187-35 ( EudraCT Number )
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbro Hedin Skogman, Dalarna County Council, Sweden:
Children
Paediatric
Additional relevant MeSH terms:
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Borrelia Infections
Bell Palsy
Facial Paralysis
Facial Nerve Diseases
Paralysis
Facies
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Cortisone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids