Clinical trial • Phase IV • Neurology

Prednisolone for Facial nerve palsy (Bell's palsy)

Phase IV trial of Prednisolone for Facial nerve palsy (Bell's palsy).

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Facial nerve palsy (Bell's palsy)
Trial Stage
Phase IV
Drug Modality
Small molecule|Other
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
16-05-2024
First CTIS Authorization Date
24-05-2024

Trial design

Randomised, prednisolone (oral) vs placebo capsules corresponding to prednisolone 5 mg for oral administration. product data show prednisolone with maxdailydoseamount = 50 mg, maxtotaldoseamount = 500 mg, maxtreatmentperiod = 10 days; exact daily dosing regimen for participants is not specified in the ctis record.-controlled Phase IV trial across 19 sites in Sweden.

Randomised
Yes
Comparator
Prednisolone (oral) vs placebo capsules corresponding to Prednisolone 5 mg for oral administration. Product data show Prednisolone with maxDailyDoseAmount = 50 mg, maxTotalDoseAmount = 500 mg, maxTreatmentPeriod = 10 days; exact daily dosing regimen for participants is not specified in the CTIS record.
Target Sample Size
500
Trial Duration For Participant
365

Eligibility

Recruits 500 paediatric patients.

Pregnancy Exclusion
Pregnancy or breastfeeding
Vulnerable Population
Children aged 1-17 years are included (isVulnerablePopulationSelected = true). Signed informed consent is required. Subject information and informed consent form documents exist for parents and for children (documents listed: L1_SIS children 8-17 years_Redacted; L1_SIS parents_Redacted; L1_ICF parents_redacted). Children (minors) require parental consent; age-specific information/consent materials available for children aged 8-17 years. Specific assent procedures beyond the presence of child information forms are not detailed.

Inclusion criteria

  • {"criterion_text":"- 1-17 years of age"}
  • {"criterion_text":"- Acute peripheral facial nerve palsy"}
  • {"criterion_text":"- Less than 72 hours of duration of symptoms"}
  • {"criterion_text":"- Signed informed consent."}

Exclusion criteria

  • {"criterion_text":"- Trauma"}
  • {"criterion_text":"- Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms"}
  • {"criterion_text":"- Immunization with live vaccine 1 month prior onset of symptoms"}
  • {"criterion_text":"- Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)"}
  • {"criterion_text":"- Evaluation of primary endpoint at 12 months not feasible for any reason"}
  • {"criterion_text":"- Previously included into the FACE study"}
  • {"criterion_text":"- Central facial nerve palsy"}
  • {"criterion_text":"- Malformations in head and neck"}
  • {"criterion_text":"- Conditions not compatible with cortisone treatment (hypertension, diabetes mellitus type 1, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)"}
  • {"criterion_text":"- Current or past oncological diagnosis"}
  • {"criterion_text":"- Other serious medical conditions (meningitis, encephalitis, stroke)"}
  • {"criterion_text":"- Acute otitis media"}
  • {"criterion_text":"- Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)"}
  • {"criterion_text":"- Pregnancy or breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary endpoint is the number of patients with total recovery of the facial nerve palsy measured by the House-Brackmann grading scale at 12 months follow-up. This is chosen to be a robust primary endpoint which has also been used in previous studies in pediatric and adult patients.","definition_or_measurement_approach":"Total recovery measured using the House-Brackmann grading scale at 12 months follow-up (count of patients with total recovery)."}

Secondary endpoints

  • {"endpoint_text":"- The total number of patients with total recovery, measured by the Sunnybrook grading scale at 12 months follow-up, in the two subgroups of patients with idiopathic or Borrelia associated facial nerve palsy.","definition_or_measurement_approach":"Total recovery measured by the Sunnybrook grading scale at 12 months; analysis in subgroups (idiopathic vs Borrelia-associated)."}
  • {"endpoint_text":"- The total recovery rate with both Sunnybrook and House-Brakmann scales at 1 month compared to 12 months.","definition_or_measurement_approach":"Comparison of total recovery rates at 1 month versus 12 months using Sunnybrook and House-Brackmann scales."}
  • {"endpoint_text":"- Subjective symptoms and influence in Daily Life with the Facial Clinimetric Evaluation (FaCE) scale, the Facial Disability Index (FDI) and the Synkinesis Assessment Questionnaire (SAQ) at 1 and 12 months follow-up.","definition_or_measurement_approach":"Patient-reported outcome measures: FaCE, FDI and SAQ assessed at 1 and 12 months."}
  • {"endpoint_text":"- Safety profile by adverse event reporting.","definition_or_measurement_approach":"Safety assessed by adverse event reporting (AE collection and reporting)."}

Recruitment

Planned Sample Size
500
Recruitment Window Months
91
Consent Approach
Signed informed consent is required. Subject information and informed consent form documents exist for parents and for children (L1_SIS children 8-17 years_Redacted; L1_SIS parents_Redacted; L1_ICF parents_redacted). Parents provide consent for minors; information/consent forms are age-specific (documents for children aged 8-17 years). Languages available are not specified in the CTIS record.

Geography

Total Number Of Sites
19
Total Number Of Participants
500

Sweden

Earliest CTIS Part Ii Submission Date
10-04-2024
Latest Decision Or Authorization Date
14-05-2025
Processing Time Days
399
Number Of Sites
19
Number Of Participants
500

Sites

Site Name
Region Dalarna
Department Name
Barn och ungdomsmedicinsk mottagning Falu Lasarett 791 31 Falun
Contact Person Name
Barbro Hedin Skogman
Site Name
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
Department Name
Drottnings Silvias Barn- och ungdomssjukhus Göteborg
Contact Person Name
Katarina Adrian
Contact Person Email
katarina.adrian@vgregion.se
Site Name
Uppsala University Hospital
Department Name
Akutmottagningen för barn och ungdom Barnsjukhuset 751 85 UPPSALA
Contact Person Name
Åsa Laestadius
Contact Person Email
asa.laestadius@akademiska.se
Site Name
Region Skane Helsingborg Hospital
Department Name
Barnavdelningen, Helsingborgs Lasarett, 251 87 Helsingborg
Contact Person Name
Hillevi Nordengren
Contact Person Email
Hillevi.Nordengren@skane.se
Site Name
Soedersjukhuset AB
Department Name
Sachsska barn- och ungdomssjukhuset Sjukhusbacken 10 Södersjukhuset 118 83 STOCKHOLM
Contact Person Name
Charlotta Nordenhäll
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Skånes universitetssjukhus Barnakuten Akutgatan 4 221 85 Lund
Contact Person Name
Karin Stålhammar
Contact Person Email
karin.stalhammar@skane.se
Site Name
Region Skane Kristianstad Central Hospital
Department Name
Barn- och ungdomsmottagningen, Centralsjukhuset, 291 85 Kristianstad
Contact Person Name
Ulrike Schmidt
Contact Person Email
Ulrike.Schmidt@skane.se
Site Name
Sodra Alvsborg Hospital Vastra Gotalandsregionen
Department Name
Barn- och Ungdomskliniken, Södra Älvsborgs Sjukhus 504 55 Borås
Contact Person Name
Athanasios Sousoulas
Site Name
Skaraborg Hospital-Vastra Gotalandsregionen
Department Name
Barn- och ungdomskliniken, Skaraborgs Sjukhus, 541 85 Skövde
Contact Person Name
Carl-Johan Törnhage
Site Name
Region Vaestmanland
Department Name
Barn- och ungdomskliniken Dagsjukvården Barn Västmanlands sjukhus 721 89 Västerås
Contact Person Name
Annika Gunnarsson
Site Name
Region Oerebro Laen
Department Name
Barn- och ungdoms-mottagningen Universitetssjukhuset Örebro 701 85 Örebro
Contact Person Name
Nisse Sandlund
Site Name
Region Joenkoepings Laen
Department Name
Barn och ungdomsmedicinska kliniken
Contact Person Name
Thea Hamell
Contact Person Email
thea.hamell@rjl.se
Site Name
Laenssjukhuset I Kalmar Region Kalmar Laen
Department Name
Barn- och ungdomskliniken Länssjukhuset 391 85 Kalmar
Contact Person Name
Anna Röckert Tjernberg
Contact Person Email
anna.rockert@regionkalmar.se
Site Name
Region Oestergoetland
Department Name
Barnmottagning, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus
Contact Person Name
Peter Wide
Site Name
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Department Name
Barn- och ungdomskliniken Vrinnevisjukhuset 603 79 NORRKÖPING
Contact Person Name
Maria Nordwall
Site Name
Region Blekinge
Department Name
Barn och ungdomskliniken, Blekingesjukhuset, 371 85 Karlskrona
Contact Person Name
Mia Olsson Engman
Contact Person Email
mia.engman@regionblekinge.se
Site Name
Karolinska University Hospital
Department Name
Astrid Lindgrens Barnsjukhus Karolinska Universitetssjukhuset 171 64 SOLNA
Contact Person Name
Sigurdur Arnason
Site Name
Karolinska University Hospital
Department Name
FO Akutvård Barn, Barnakuten Huddinge
Contact Person Name
Åsa Fowler
Contact Person Email
asa.fowler@regionstockholm.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Skånes universitetssjukhus Barnakuten Ruth Lundskogs gata 5 205 02 MALMÖ
Contact Person Name
Anna Karlsson
Contact Person Email
anna.lindow@skane.se

Sponsor

Primary sponsor

Full Name
Region Dalarna
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
PREDNISOLONE
Active Substance
Prednisolone
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus=2, euMpNumber=SCP1158234
Maximum Dose
50 mg daily; max total 500 mg
Investigational Product Name
Placebo capsules corresponding to Prednisolone 5 mg for oral administration.
Modality
Other
Starting Dose
corresponding to Prednisolone 5 mg

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