Clinical Trials Nct Page

Summary
EudraCT Number:2017-004187-35
Sponsor's Protocol Code Number:FACE-01
National Competent Authority:Sweden - MPA
Clinical Trial Type:EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:2018-10-31
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedSweden - MPA
A.2EudraCT number2017-004187-35
A.3Full title of the trial
The FACE (Facial nerve palsy And Cortisone Evaluation) study in children: a randomised double-blind, placebo-controlled, multicenter trial.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Evaluation of cortisone treatment in children suffering from acute facial nerve paralysis.
A.4.1Sponsor's protocol code numberFACE-01
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorFalun Hospital
B.1.3.4CountrySweden
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportAcademic funding
B.4.2CountrySweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationFalun Hospital
B.5.2Functional name of contact pointBarn och ungdomsmedicin
B.5.3 Address:
B.5.3.1Street AddressNissers väg 3
B.5.3.2Town/ cityUppsala
B.5.3.3Post code791 82
B.5.3.4CountrySweden
B.5.4Telephone number0046(0)2349 20 00
B.5.6E-mailbarbro.hedinskogman@ltdalarna.se
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Prednisolon Alternova
D.2.1.1.2Name of the Marketing Authorisation holderOrifarm Generics AB
D.2.1.2Country which granted the Marketing AuthorisationSweden
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namePrednisolon Alternova
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPGastroenteral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNPrednisolone
D.3.9.3Other descriptive namePREDNISOLONE
D.3.9.4EV Substance CodeSUB10018MIG
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5 to 60
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboTablet
D.8.4Route of administration of the placeboGastroenteral use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Facial Nerve Palsy (Bells Palsy)
E.1.1.1Medical condition in easily understood language
Facial paralysis
E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10077335
E.1.2Term Facial nerve paresis
E.1.2System Organ Class 100000004852
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To evaluate the efficacy of cortisone versus placebo treatment in children with acute facial nerve palsy.
E.2.2Secondary objectives of the trial
To evaluate the total recovery rate 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 in children with acute facial nerve palsy.

To evaluate the safety profile for cortisone in children with acute facial nerve palsy.





E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1.1-17 years of age
2.Acute peripheral facial nerve palsy
3.Less than 72 hours of duration of symptoms
4.Signed informed consent.
E.4Principal 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 (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
E.5 End points
E.5.1Primary end point(s)
The primary endpoint is the total recovery rate at 12 months follow-up in the two treatment groups measured with the House-Brackmann scale.
E.5.1.1Timepoint(s) of evaluation of this end point
12 months follow-up
E.5.2Secondary end point(s)
The total recovery rate at 12 months follow-up in the two treatment groups measured with the Sunnybrook scale.

The total recovery rate at 1 month follow-up as compared to the total recovery rate at 12 months follow-up, measured with Sunnybrook and House-Brackmann scale (predicition)

Quality of Daily Life at 1 and 12 months follow-up measured with the Facial Clinimetric Evaluation (FaCE ) scale and the Facial Disability Index (FDI) and at the 12 months measured with the Synkinesis Assessment Questionnaire (SAQ)

Number of Adverse Events possibly or probably related to the study drug during the 12 months follow-up
E.5.2.1Timepoint(s) of evaluation of this end point
One and twelve months follow-up.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned10
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
Last visit of the last subject.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1Number of subjects for this age range: 500
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) Yes
F.1.1.4.1Number of subjects for this age range: 50
F.1.1.5Children (2-11years) Yes
F.1.1.5.1Number of subjects for this age range: 300
F.1.1.6Adolescents (12-17 years) No
F.1.1.6.1Number of subjects for this age range: 150
F.1.2Adults (18-64 years) No
F.1.2.1Number of subjects for this age range: 0
F.1.3Elderly (>=65 years) No
F.1.3.1Number of subjects for this age range: 0
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
Children (<18 years old) requiring informed consent from guardians.
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state500
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
The treatment period is limited to 10 days. No planned treatment post-study. If the patients have permanent or residual injuries from the facial nerve palsy, the patient will be treated according to normal clinical routines.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2018-12-11
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial Status

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