Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
500
Countries
1
Sites
19
Facial Nerve Palsy (Bells Palsy)
To evaluate the efficacy of cortisone versus placebo treatment in children with acute facial nerve palsy, measured as total recovery with the House-Brackmann scale at 12 months follow-up.
Key facts
- Sponsor
- Region Dalarna
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 1 Jun 2019 → ongoing
- Decision date (initial)
- 2024-05-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513430-37-00
- EudraCT number
- 2017-004187-35
- ClinicalTrials.gov
- NCT03781700
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the efficacy of cortisone versus placebo treatment in children with acute facial nerve palsy, measured as total
recovery with the House-Brackmann scale at 12 months follow-up.
Secondary objectives 4
- To evaluate the efficacy of cortisone versus placebo treatment in children with acute facial nerve palsy measured as total recovery with the Sunnybrook scale at 12 months follow-up.
- To evaluate the total recovery rate with both Sunnybrook and House-Brackmann scale at 1 month as compared to the total recovery rate at 12 months, in order to evaluate if prediction of recovery at 1 month is feasible and/or useful in children with acute facial nerve palsy.
- To evaluate 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.
- To evaluate the safety profile for cortisone in children suffering from acute facial nerve palsy.
Conditions and MedDRA coding
Facial Nerve Palsy (Bells Palsy)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10077335 | Facial nerve paresis | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1-17 years of age
- Acute peripheral facial nerve palsy
- Less than 72 hours of duration of symptoms
- Signed informed consent.
Exclusion criteria 14
- Trauma
- Central facial nerve palsy
- Malformations in head and neck
- Conditions not compatible with cortisone treatment (hypertension, diabetes mellitus type 1, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
- Current or past oncological diagnosis
- Other serious medical conditions (meningitis, encephalitis, stroke)
- Acute otitis media
- Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
- Pregnancy or breastfeeding
- Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
- Immunization with live vaccine 1 month prior onset of symptoms
- Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
- Evaluation of primary endpoint at 12 months not feasible for any reason
- Previously included into the FACE study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 4
- 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.
- The total recovery rate with both Sunnybrook and House-Brakmann scales at 1 month compared to 12 months.
- 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.
- Safety profile by adverse event reporting.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP1158234 · ATC
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo capsules corresponding to Prednisolone 5 mg for oral administration.
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Dalarna
- Sponsor organisation
- Region Dalarna
- Address
- Vasagatan 27, Falu Kristine Falu Kristine
- City
- Falun
- Postcode
- 791 37
- Country
- Sweden
Scientific contact point
- Organisation
- Region Dalarna
- Contact name
- Barn och ungdomsmedicin
Public contact point
- Organisation
- Region Dalarna
- Contact name
- Barn och ungdomsmedicin
Locations
1 EU/EEA country · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 500 | 19 |
| Rest of world | — | 0 | — |
Investigational sites
Soedersjukhuset AB
Sachsska barn- och ungdomssjukhuset Sjukhusbacken 10 Södersjukhuset 118 83 STOCKHOLM, Sjukhusbacken 10, Hogalid, Stockholm
Uppsala University Hospital
Akutmottagningen för barn och ungdom Barnsjukhuset 751 85 UPPSALA, Akademiska Sjukhuset, 751 85, Uppsala
Region Skane Skanes Universitetssjukhus
Skånes universitetssjukhus Barnakuten Akutgatan 4 221 85 Lund, Entregatan 7, 222 42, Lund
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Barn- och ungdomskliniken Vrinnevisjukhuset 603 79 NORRKÖPING, S Borg, Gamla Ovagen 25, Norrkoping
Karolinska University Hospital
Astrid Lindgrens Barnsjukhus Karolinska Universitetssjukhuset 171 64 SOLNA, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
Skånes universitetssjukhus Barnakuten Ruth Lundskogs gata 5 205 02 MALMÖ, St. Johns, Fritz Bauers Gata 5, Malmo
Region Dalarna
Barn och ungdomsmedicinsk mottagning Falu Lasarett 791 31 Falun, Vasagatan 27, Falu Kristine, Falun
Region Oerebro Laen
Barn- och ungdoms-mottagningen Universitetssjukhuset Örebro 701 85 Örebro, Sodra Grev Rosengatan, 701 85, Orebro
Region Skane Helsingborg Hospital
Barnavdelningen, Helsingborgs Lasarett, 251 87 Helsingborg, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Region Skane Kristianstad Central Hospital
Barn- och ungdomsmottagningen, Centralsjukhuset, 291 85 Kristianstad, J A Hedlunds Vag 5, Kristianstads Heliga Trefaldighet, Kristianstad
Sodra Alvsborg Hospital Vastra Gotalandsregionen
Barn- och Ungdomskliniken, Södra Älvsborgs Sjukhus 504 55 Borås, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Region Joenkoepings Laen
Barn och ungdomsmedicinska kliniken, Lanssjukhuset Ryhov, Sjukhusgatan, Jonkoping
Region Oestergoetland
Barnmottagning, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Region Blekinge
Barn och ungdomskliniken, Blekingesjukhuset, 371 85 Karlskrona, Lasarettsvagen, 371 85, Karlskrona
Region Vaestmanland
Barn- och ungdomskliniken Dagsjukvården Barn Västmanlands sjukhus 721 89 Västerås, Regionhuset, 721 89, Vasteras
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
Drottnings Silvias Barn- och ungdomssjukhus Göteborg, Behandlingsvagen 7, Harlanda, Gothenburg
Skaraborg Hospital-Vastra Gotalandsregionen
Barn- och ungdomskliniken, Skaraborgs Sjukhus, 541 85 Skövde, Lovangsvagen 1, 541 42, Skovde
Laenssjukhuset I Kalmar Region Kalmar Laen
Barn- och ungdomskliniken Länssjukhuset 391 85 Kalmar, Lasarettsvagen 8, Kalmar S:t Johannes, Kalmar
Karolinska University Hospital
FO Akutvård Barn, Barnakuten Huddinge, Halsovagen, Flemingsberg, Huddinge
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2019-06-01 | 2019-06-01 | 2025-07-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF parents_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS children 8-17 years_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS IMP information | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS parents_Redacted | 2.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-16 | Sweden | Acceptable 2024-05-24
|
2024-05-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-14 | Sweden | Acceptable 2024-05-24
|
2025-05-14 |