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    Clinical Trial Results:
    Can stimulation of the nNOS system in muscle disease with nNOS insufficiency improve heart and skeletal muscle function and cognition?

    Summary
    EudraCT number
    		 2010-024659-10
    Trial protocol
    		 DK  
    Global end of trial date
    17 Jan 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 Sildenafil published paper

    Trial information

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    Trial identification
    Sponsor protocol code
    2010-024659-10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01350154
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Righospitalet
    Sponsor organisation address
    6921NM, Rigshospitalet, KBH Ø, Denmark, 2100
    Public contact
    Neuromuscular Research Unit and Dept Neurol, Rigshospitalet, Copenhagen University Hospital, Neuromuscular Research Unit and Dept Neurol, Rigshospitalet, Copenhagen University Hospital, 0045 35453545, nanna.witting@regionh.dk
    Scientific contact
    Neuromuscular Research Unit and Dept Neurol, Rigshospitalet, Copenhagen University Hospital, Neuromuscular Research Unit and Dept Neurol, Rigshospitalet, Copenhagen University Hospital, 35456921 35453545, nanna.witting@regionh.dk
    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
    01 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    There are 3 parallel sub-studies Substudy 1;Effect of Sildenafil on handgrip capacity Substudy 2; heart enddiastolic volume Substudy 3; Stimulated brain blood flow and cognition
    Protection of trial subjects
    Minimal intervention
    Background therapy
    		 None
    Evidence for comparator
    		 Please see Ann Neurol . 2014 Oct;76(4):550-7. doi: 10.1002/ana.24216. Epub 2014 Jul 15. Effect of sildenafil on skeletal and cardiac muscle in Becker muscular dystrophy Nanna Witting et al
    Actual start date of recruitment
    23 Aug 2011
    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
    Denmark: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Ann Neurol . 2014 Oct;76(4):550-7. doi: 10.1002/ana.24216. Epub 2014 Jul 15. Effect of sildenafil on skeletal and cardiac muscle in Becker muscular dystrophy Nanna Witting 1, Christina Kruuse, Bo Nyhuus, Kira P Prahm, Gulsenay Citirak, Stine J Lundgaard, Sebastian von Huth, Niels Vejlstrup, Ulrich Lindberg, Thomas O Krag, John Vissing

    Pre-assignment
    Screening details
    		 Ann Neurol . 2014 Oct;76(4):550-7. doi: 10.1002/ana.24216. Epub 2014 Jul 15. Effect of sildenafil on skeletal and cardiac muscle in Becker muscular dystrophy Nanna Witting 1, Christina Kruuse, Bo Nyhuus, Kira P Prahm, Gulsenay Citirak, Stine J Lundgaard, Sebastian von Huth, Niels Vejlstrup, Ulrich Lindberg, Thomas O Krag, John Vissing

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

    Arms
    Arm title
    		 Active 1
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    cc to published paper attached

    Number of subjects in period 1
    		Active 1
    Started
    16
    Completed
    16
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Active 2
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sildenafil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Please see Ann Neurol . 2014 Oct;76(4):550-7. doi: 10.1002/ana.24216. Epub 2014 Jul 15. Effect of sildenafil on skeletal and cardiac muscle in Becker muscular dystrophy Nanna Witting 1, Christina Kruuse, Bo Nyhuus, Kira P Prahm, Gulsenay Citirak, Stine J Lundgaard, Sebastian von Huth, Niels Vejlstrup, Ulrich Lindberg, Thomas O Krag, John Vissing

    Number of subjects in period 2
    		Active 2
    Started
    16
    Completed
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1.period
    Reporting group description
    		 -

    Reporting group values
    		 1.period Total
    Number of subjects
    		 16 16
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 16 16
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    brachial artery blood flow during maximal handgrip
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    brachial artery blood flow during maximal handgrip

    Subject analysis sets values
    		 brachial artery blood flow during maximal handgrip
    Number of subjects
    16
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    16
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    16

    End points

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    End points reporting groups
    Reporting group title
    Active 1
    Reporting group description
    		 -
    Reporting group title
    Active 2
    Reporting group description
    		 -

    Subject analysis set title
    brachial artery blood flow during maximal handgrip
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    brachial artery blood flow during maximal handgrip

    Primary: brachial artery blood flow during maximal handgrip

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    End point title
    		 brachial artery blood flow during maximal handgrip
    End point description
    brachial artery blood flow during maximal handgrip
    End point type
    Primary
    End point timeframe
    4W
    End point values
    		 Active 1 Active 2 brachial artery blood flow during maximal handgrip
    Number of subjects analysed
    16
    16
    16
    Units: ml/min
        number (not applicable)
    16
    16
    16
    Statistical analysis title
    		 one-way ANOVA for repeated measures
    Comparison groups
    Active 1 v Active 2 v brachial artery blood flow during maximal handgrip
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12W
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    period 2
    Reporting group description
    		 -

    Serious adverse events
    		 period 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 period 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Please see published paper attached

    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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