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    Clinical Trial Results:
    Clinical trial to determine the effect of Famciclovir on Epstein-Barr virus activity as measured by EBV shedding in saliva of patients with Multiple Sclerosis.

    Summary
    EudraCT number
    		 2019-000169-19
    Trial protocol
    		 GB  
    Global end of trial date
    10 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2024
    First version publication date
    07 Nov 2024
    Other versions
    Summary report(s)
    		 Accepted paper
    Protocol

    Trial information

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    Trial identification
    Sponsor protocol code
    249627 v5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05283551
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    Mile End Road, London, United Kingdom, E1 4NS
    Public contact
    Dr Mays Jawad, Queen Mary University London, 0044 02078827260, research.governance@qmul.ac.uk
    Scientific contact
    Dr Mays Jawad, Queen Mary University London, 0044 02078827260, research.governance@qmul.ac.uk
    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
    07 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of this study is to explore the effect of famciclovir (500mg twice daily) on Epstein Barr virus shedding in the saliva of people with MS.
    Protection of trial subjects
    Standard
    Background therapy
    		 -
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    01 Jun 2019
    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
    United Kingdom: 30
    Worldwide total number of subjects
    30
    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)
    0
    Adults (18-64 years)
    29
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited as per protocol

    Pre-assignment
    Screening details
    		 Screening as per protocol

    Period 1
    Period 1 title
    Pre drug
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single arm internal case control design - pre drug

    Arms
    Arm title
    		 Study population
    Arm description
    		 Entire study population
    Arm type
    		 pre drug

    Investigational medicinal product name
    NONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    NO DRUG GIVEN

    Number of subjects in period 1
    		Study population
    Started
    30
    Completed
    29
    Not completed
    1
         Consent withdrawn by subject
    1
    Period 2
    Period 2 title
    On drug
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single arm internal control design

    Arms
    Arm title
    		 Trial population
    Arm description
    		 Entire study population
    Arm type
    		 Experimental

    Investigational medicinal product name
    famciclovir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500mg twice daily oral

    Number of subjects in period 2
    		Trial population
    Started
    29
    Completed
    24
    Not completed
    5
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    2
    Period 3
    Period 3 title
    Post drug
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Single arm internal control design

    Arms
    Arm title
    		 Study population
    Arm description
    		 Entire study population
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Study population
    Started
    24
    Completed
    24

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Study population
    Reporting group description
    		 Entire study population
    Reporting group title
    Trial population
    Reporting group description
    		 Entire study population
    Reporting group title
    Study population
    Reporting group description
    		 Entire study population

    Primary: Salivary EBV DNA shedding

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    End point title
    		 Salivary EBV DNA shedding
    End point description
    Viral shedding was defined as a salivary EBV concentration greater than 5.8 copies/ul, with viral presence defined as any detectable EBV DNA in saliva. The number of samples in each epoch with (a) viral shedding, and (b) viral presence, were recorded as a proportion of total samples
    End point type
    Primary
    End point timeframe
    During study
    End point values
    		 Study population Trial population Study population
    Number of subjects analysed
    21 [1]
    21 [2]
    21 [3]
    Units: presence or absence
        Viral shedding
    48
    33
    23
        Viral presence
    48
    40
    54
        No viral DNA
    52
    60
    46
    Notes
    [1] - those with at least one sample meeting QC requirements available across all epochs
    [2] - those with at least one sample meeting QC requirements available across all epochs
    [3] - those with at least one sample meeting QC requirements available across all epochs
    Statistical analysis title
    		 Primary outcome measure
    Statistical analysis description
    The primary outcome measure, the rate of EBV shedding in saliva, was assessed as a proportion in the pre-treatment and the on-treatment epochs. As the on-treatment groups were expected to be skewed, paired proportions were compared using the Wilcoxon Signed-Rank Test.
    Comparison groups
    Study population v Trial population v Study population
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - As above

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From trial initiation until EoT
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    29
    Reporting groups
    Reporting group title
    Entire study population
    Reporting group description
    		 Entire study population

    Serious adverse events
    		 Entire study population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine polypectomy
    Additional description: Admitted for removal of uterine polyp
         subjects affected / exposed [1]
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary resection
    Additional description: VATS wedge procedure for removal of nodule (subsequently found to be benign)
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankle fracture
    Additional description: Required surgical management
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only females could be exposed to this AE given gender-specific AE (Uterine polypectomy). Of 30 participants, 19 were female (please see page 2 of "Accepted paper/FamV paper_v3_revised_clean.docx" in "Summary attachments" section. 1 subject was affected out of 19 female subjects that could be exposed to an Uterine polypectomy.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Entire study population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 30 (60.00%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Sensory disturbance
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Haematoma
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Pneumothorax
    Additional description: Following VATS procedure (see SAE)
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Herpes simplex reactivation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Synovitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    COVID-19
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    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? Yes
    Date
    Interruption
    Restart date
    23 Mar 2020
    COVID - related with gradual restart
    -

    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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