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    Clinical Trial Results:
    A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living

    Summary
    EudraCT number
    		 2018-003426-89
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2019
    First version publication date
    17 Feb 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    E2020-J081-345
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02094053
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai Co., Ltd.
    Sponsor organisation address
    Koishikawa 4-6-10, Bunkyo-ku, Tokyo, Japan, 1128088
    Public contact
    Eisai Medical Information, Eisai Inc, 81 120161454, eisai-chiken_hotline@hhc.eisai.co.jp
    Scientific contact
    Eisai Medical Information, Eisai Inc, 81 120161454, eisai-chiken_hotline@hhc.eisai.co.jp
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate dose-response of E2020 in change of the total score of the Body Functionality Checklist (psychosomatic function questionnaire) from baseline relative to placebo in subject s with Down syndrome who have regression symptoms and disabled activities of daily living.
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    38
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study at 13 investigative sites in Japan from 12 September 2013 to 21 April 2017.

    Pre-assignment
    Screening details
    		 A total of 54 subjects were enrolled in the study, of which 2 subjects were screen failures. 52 subjects started and 9 subjects discontinued the observation phase. The 43 subjects who completed the observation phase were then randomized to receive study treatment in the treatment period.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Period: Placebo
    Arm description
    		 Subjects received E2020 matching-placebo granules, orally, once daily, for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    E2020 matching-placebo granules, orally, once daily, for 24 weeks.

    Arm title
    		 Treatment Period: E2020 3 milligram (mg)
    Arm description
    		 Subjects received E2020 3 mg granules, orally, once daily, for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Donepezil Hydrochloride 3 mg
    Investigational medicinal product code
    E2020
    Other name
    Aricept
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    E2020 3 mg granules, orally, once daily, for 24 weeks.

    Arm title
    		 Treatment Period: E2020 5 mg
    Arm description
    		 Subjects received E2020 5 mg granules, orally, once daily, for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Donepezil Hydrochloride 5 mg
    Investigational medicinal product code
    E2020
    Other name
    Aricept
    Pharmaceutical forms
    Granules
    Routes of administration
    Other use
    Dosage and administration details
    E2020 5 mg granules, orally, once daily, for 24 weeks.

    Number of subjects in period 1
    		Treatment Period: Placebo Treatment Period: E2020 3 milligram (mg) Treatment Period: E2020 5 mg
    Started
    15
    14
    14
    Completed
    15
    14
    13
    Not completed
    0
    0
    1
         Disease Progression
    -
    -
    1
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Extension Phase: E2020 3 mg
    Arm description
    		 Subjects received E2020 3 mg granules, orally, once daily, for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Donepezil Hydrochloride 3 mg
    Investigational medicinal product code
    E2020
    Other name
    Aricept
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    E2020 3 mg granules, orally, once daily, for 24 weeks.

    Number of subjects in period 2 [1]
    		Extension Phase: E2020 3 mg
    Started
    41
    Completed
    36
    Not completed
    5
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    2
         Unspecified
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One subject discontinued the study during transition from Treatment period to Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period: Placebo
    Reporting group description
    		 Subjects received E2020 matching-placebo granules, orally, once daily, for 24 weeks.

    Reporting group title
    Treatment Period: E2020 3 milligram (mg)
    Reporting group description
    		 Subjects received E2020 3 mg granules, orally, once daily, for 24 weeks.

    Reporting group title
    Treatment Period: E2020 5 mg
    Reporting group description
    		 Subjects received E2020 5 mg granules, orally, once daily, for 24 weeks.

    Reporting group values
    		 Treatment Period: Placebo Treatment Period: E2020 3 milligram (mg) Treatment Period: E2020 5 mg Total
    Number of subjects
    		 15 14 14 43
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (full range (min-max))
    		 28.0 (15 to 32) 23.5 (15 to 37) 24.5 (18 to 33) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8 8 24
        Male
    		 7 6 6 19
    Race
    Units: Subjects
        Japanese
    		 14 14 14 42
        Unknown or Not Reported
    		 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Treatment Period: Placebo
    Reporting group description
    		 Subjects received E2020 matching-placebo granules, orally, once daily, for 24 weeks.

    Reporting group title
    Treatment Period: E2020 3 milligram (mg)
    Reporting group description
    		 Subjects received E2020 3 mg granules, orally, once daily, for 24 weeks.

    Reporting group title
    Treatment Period: E2020 5 mg
    Reporting group description
    		 Subjects received E2020 5 mg granules, orally, once daily, for 24 weeks.
    Reporting group title
    Extension Phase: E2020 3 mg
    Reporting group description
    		 Subjects received E2020 3 mg granules, orally, once daily, for 24 weeks.

    Primary: Change from Week 0 (Baseline) in Total Score Using Body Functionality Checklist (Psychosomatic Function Questionnaire) at Week 24 (Last Assessment) in Treatment Period

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    End point title
    		 Change from Week 0 (Baseline) in Total Score Using Body Functionality Checklist (Psychosomatic Function Questionnaire) at Week 24 (Last Assessment) in Treatment Period
    End point description
    The Body Functionality Checklist is a testing method developed as an assessment scale for regression/premature aging of the intellectually disabled. The subject’s functionality of each item was evaluated on a five-point scale from the viewpoint of the caregiver and a higher point (the total score [51 items] 51 range, 51-255 points) suggests better body functionality of the subject. The full analysis set (FAS) included all subjects who received the study drug for the Treatment Period after randomization and had evaluable efficacy data at 1 or more time points after administration of the study drug for the Treatment Period.
    End point type
    Primary
    End point timeframe
    Week 0 (Baseline) and Week 24 (Last assessment) of Treatment Period
    End point values
    		 Treatment Period: Placebo Treatment Period: E2020 3 milligram (mg) Treatment Period: E2020 5 mg
    Number of subjects analysed
    15
    14
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    9.8 ( 13.2 )
    6.6 ( 10.4 )
    7.7 ( 16.4 )
    Statistical analysis title
    		 Treatment Period: Placebo v Treatment Period: E202
    Comparison groups
    Treatment Period: Placebo v Treatment Period: E2020 3 milligram (mg)
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.229
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Cox proportional hazard
    Confidence interval
    Statistical analysis title
    		 Treatment Period: Placebo v Treatment Period: E202
    Comparison groups
    Treatment Period: Placebo v Treatment Period: E2020 5 mg
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.419
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Number of Subjects with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)

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    End point title
    		 Number of Subjects with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAE)
    End point description
    The safety analysis set (SAS) included all subjects who received the study drug for the Treatment Period and had evaluable safety data at 1 or more time points after administration of the study drug for the Treatment Period.
    End point type
    Secondary
    End point timeframe
    From date of first dose up to Follow-up period (Week 56)
    End point values
    		 Treatment Period: Placebo Treatment Period: E2020 3 milligram (mg) Treatment Period: E2020 5 mg Extension Phase: E2020 3 mg
    Number of subjects analysed
    15
    14
    14
    41
    Units: subjects
        TEAE
    9
    12
    13
    29
        SAEs
    0
    0
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of first dose up to Follow-up period (Week 56)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Treatment Period: Placebo
    Reporting group description
    		 Subjects received E2020 matching-placebo granules, orally, once daily, for 24 weeks.

    Reporting group title
    Treatment Period: E2020 3 mg
    Reporting group description
    		 Subjects received E2020 3 mg granules, orally, once daily, for 24 weeks.

    Reporting group title
    Treatment Period: E2020 5 mg
    Reporting group description
    		 Subjects received E2020 5 mg granules, orally, once daily, for 24 weeks.

    Reporting group title
    Extension Phase: E2020 3 mg
    Reporting group description
    		 Subjects received E2020 3 mg granules, orally, once daily, for 24 weeks.

    Serious adverse events
    		 Treatment Period: Placebo Treatment Period: E2020 3 mg Treatment Period: E2020 5 mg Extension Phase: E2020 3 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 41 (4.88%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Eye disorders
    Retinopathy proliferative
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment Period: Placebo Treatment Period: E2020 3 mg Treatment Period: E2020 5 mg Extension Phase: E2020 3 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 15 (60.00%)
    12 / 14 (85.71%)
    13 / 14 (92.86%)
    29 / 41 (70.73%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    0
    8
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 14 (7.14%)
    2 / 14 (14.29%)
    2 / 41 (4.88%)
         occurrences all number
    1
    1
    2
    2
    Asthma
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 14 (14.29%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Intentional self-injury
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    0
    2
    Sleep disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Aggression
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Hallucination, visual
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Initial insomnia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Mental disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Affect lability
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Blood potassium increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    White blood cell count increased
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arthropod sting
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chillblains
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Excoriation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Bradykinesia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eczema eyelids
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cataract
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Eye inflammation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 14 (14.29%)
    3 / 14 (21.43%)
    3 / 41 (7.32%)
         occurrences all number
    2
    4
    7
    3
    Dental caries
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 14 (14.29%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    5
    0
    Faeces soft
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    0
    1
    0
    3
    Tongue disorder
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Cheilitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    3 / 15 (20.00%)
    0 / 14 (0.00%)
    2 / 14 (14.29%)
    1 / 41 (2.44%)
         occurrences all number
    3
    0
    2
    1
    Rash
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Petechiae
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    0
    2
    Dermatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    2
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
    4 / 14 (28.57%)
    7 / 14 (50.00%)
    10 / 41 (24.39%)
         occurrences all number
    1
    4
    8
    12
    Conjunctivitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Influenza
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth abscess
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    0
    2
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Subcutaneous abscess
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Dermatophytosis of nail
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Impetigo
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 14 (14.29%)
    1 / 14 (7.14%)
    1 / 41 (2.44%)
         occurrences all number
    0
    2
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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