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    Clinical Trial Results:
    Pilot study to establish laboratory methods for urine Nerve Growth Factor (NGF) and immunohistochemical staining of the vanilloid receptor (TRPV1) in bladder biopsies, following open label treatment with botulinum neurotoxin type A in patients with neurogenic detrusor overactivity (NDO) and idiopathic detrusor overactivity (IDO).

    Summary
    EudraCT number
    		 2010-020944-37
    Trial protocol
    		 GB  
    Global end of trial date
    07 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Dec 2018
    First version publication date
    01 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    09/0127
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Joint Research Office
    Sponsor organisation address
    1st floor Maple House, London, United Kingdom, W1T7DN
    Public contact
    Farhat Gilani, University College London, +44 2076796469, f.gilani@ucl.ac.uk
    Scientific contact
    Farhat Gilani, University College London, +44 2076796469, f.gilani@ucl.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 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish laboratory methods for detecting changes degrees of bladder stimulation via nerves following treatment with BOTOX in patients with urinary urgency incontinence due either to: -neurological disease -or of unknown origin.
    Protection of trial subjects
    Patients were all given PILs and went through an informed consent process prior to enrolment. Patient data was anonymised.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		  Males and females aged between 18 and 75 years inclusive.  The group with NDO will be comprised exclusively of patients with multiple sclerosis who are attending the Uro-Neurology clinics.  The group of patients with IDO will be comprised of patients without neurological disease but with urodynamically proven DO (detrusor overactivity) who ar

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 25
    Number of subjects completed
    		 25

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 not applicable
    Arm description
    		 -
    Arm type
    		 not applicable

    Investigational medicinal product name
    OnabotulinumtoxinA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravesical use
    Dosage and administration details
    100U to idiopathic detrusor overactivity (10x1ml injections) 200U to neurogenic detrusor overactivity (20x1ml injections)

    Number of subjects in period 1
    		not applicable
    Started
    25
    Completed
    25

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    not applicable
    Reporting group description
    		 -

    Subject analysis set title
    clinical evaluation with ICIQ-OAB, ICIQ-LUTSqol
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    clinical evaluation with ICIQ-OAB, ICIQ-LUTSqol, and 3-day bladder diary at baseline (Visit0), 2-weeks post BTX-A (Visit1), and at return of symptoms (Visit2)

    Subject analysis set title
    urinary BDNF/Creat and NGF/Creat levels
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    urinary BDNF/Creat and NGF/Creat levels also correlated with the observed clinical changes from 0.28, 0.19 and 0.29 and 0.2, 0.15, to 0.17 respectively. At the same time points decreases were also seen in BDNF and NGF bladder tissue content from 16.3, 9.14 and 11.07, and 0.41, 0.26 and 0.57 pg/g respectively.

    Primary: ICIQ-OAB and ICIQ-LUTSQOL scores

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    End point title
    		 ICIQ-OAB and ICIQ-LUTSQOL scores [1]
    End point description
    For all patients combined, across the three time points, visitO, visit1, and visit2, ICIQ-OAB scores improved at visit1 and returned to baseline by visit2, from 39.6, 13.3, and 41.3 respectively and similarly with ICIQ-LUTSqol from 193.1, 98.2 and 191.5. Similarly bladder Diary reported daily frequency episodes changed from 10.8, 6.3, 8.9, and daily urge leakage episodes changed from 6.2, 0.8, to 3 respectively over visits 1,2 and 3.
    End point type
    Primary
    End point timeframe
    14/2/2013 - 7/3/2015
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Details provided in endpoint description
    End point values
    		 not applicable clinical evaluation with ICIQ-OAB, ICIQ-LUTSqol urinary BDNF/Creat and NGF/Creat levels
    Number of subjects analysed
    19
    19
    19
    Units: QOL questionnaire score
        number (not applicable)
    19
    19
    19
    No statistical analyses for this end point

    Secondary: Urinary BDNF/Creat and NGF/Creat levels

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    End point title
    		 Urinary BDNF/Creat and NGF/Creat levels
    End point description
    At these time points urinary BDNF/Creat and NGF/Creat levels also correlated with the observed clinical changes from 0.28, 0.19 and 0.29 and 0.2, 0.15, to 0.17 respectively. At the same time points decreases were also seen in BDNF and NGF bladder tissue content from 16.3, 9.14 and 11.07, and 0.41, 0.26 and 0.57 pg/g respectively.
    End point type
    Secondary
    End point timeframe
    february 2013 - 7/3/15
    End point values
    		 not applicable clinical evaluation with ICIQ-OAB, ICIQ-LUTSqol urinary BDNF/Creat and NGF/Creat levels
    Number of subjects analysed
    25
    Units: pg/g
        number (not applicable)
    25
    25
    25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    14/2/13-7/3/15
    Adverse event reporting additional description
    2 NON SERIOUS ADVERSE EVENTS. 1 PATIENT WITH RASH - patient reported this months after treatment. 1 PATIENT WITH UTI - withdrawn from study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Sponsors definitions
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    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: There were 2 non serious AEs One UTI and One rash post botox injection These were both reported

    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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