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    Clinical Trial Results:
    Oral cannabidivarin (CBDV) solution for treatment of HIV-associated neuropathic pain – a randomized, double-blind, placebo-controlled phase II study.

    Summary
    EudraCT number
    		 2014-005344-17
    Trial protocol
    		 DE  
    Global end of trial date
    31 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2020
    First version publication date
    29 Aug 2020
    Other versions
    Summary report(s)
    		 Eibach + supplement accepted

    Trial information

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    Trial identification
    Sponsor protocol code
    CBDV_2014
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité Universitätsmedizin Berlin
    Sponsor organisation address
    Hindenburgdamm 30, Berlin, Germany, D-12200
    Public contact
    Prof. Dr. Christoph Stein, Anaesthesiology, Charité Campus Benjamin Franklin, christoph.stein@charite.de
    Scientific contact
    Prof. Dr. Christoph Stein, Anaesthesiology, Charité Campus Benjamin Franklin, christoph.stein@charite.de
    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
    15 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Modulation of neuropathic pain by cannabidivarin (CBDV) as compared to placebo
    Protection of trial subjects
    all patients provided written informed consent after extensive information about possible adverse events, as described in detail in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    Background therapy
    		 treatment of HIV by antiviral agents
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2015
    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
    Germany: 32
    Worldwide total number of subjects
    32
    EEA total number of subjects
    32
    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)
    32
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Pre-assignment
    Screening details
    		 as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Pre-assignment period milestones
    Number of subjects started
    		 32
    Number of subjects completed
    		 32

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor
    Blinding implementation details
    as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 CBDV
    Arm description
    		 as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    cannabidivarin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Arm title
    		 Placebo
    Arm description
    		 as described in manuscript posted on medRxiv: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    see posted on medRxiv: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Number of subjects in period 1
    		CBDV Placebo
    Started
    32
    32
    Completed
    32
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CBDV
    Reporting group description
    		 as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Reporting group title
    Placebo
    Reporting group description
    		 as described in manuscript posted on medRxiv: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Reporting group values
    		 CBDV Placebo Total
    Number of subjects
    		 32 32 32
    Age categorical
    as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    Units: Subjects
        Adults (18-64 years)
    		 32 32 32
        From 65-84 years
    		 0 0 0
    Gender categorical
    described in manuscript: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1
    Units: Subjects
        Female
    		 1 1 1
        Male
    		 31 31 31
    pain
    described in manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    Units: described in manuscript
        arithmetic mean (standard deviation)
    		 ( ) ( ) -
    Subject analysis sets

    Subject analysis set title
    all subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Subject analysis set title
    Pain intensity
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis set title
    Pain characteristics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis set title
    supplemental medication
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis set title
    SF 36
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis sets values
    		 all subjects Pain intensity Pain characteristics supplemental medication SF 36
    Number of subjects
    32
    32
    32
    32
    32
    Age categorical
    as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    Units: Subjects
        Adults (18-64 years)
    32
    32
    32
    32
    32
        From 65-84 years
    0
    0
    0
    0
    0
    Age continuous
    described in manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    Units: years
        arithmetic mean (standard deviation)
    50.31 ( 8.96 )
    ( )
    ( )
    ( )
    ( )
    Gender categorical
    described in manuscript: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1
    Units: Subjects
        Female
    1
    1
    1
    1
    1
        Male
    31
    31
    31
    31
    31
    pain
    described in manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    Units: described in manuscript
        arithmetic mean (standard deviation)
    2.74 ( 1.47 )
    2.74 ( 1.47 )
    ( )
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    CBDV
    Reporting group description
    		 as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Reporting group title
    Placebo
    Reporting group description
    		 as described in manuscript posted on medRxiv: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis set title
    all subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    as described in the manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)

    Subject analysis set title
    Pain intensity
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis set title
    Pain characteristics
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis set title
    supplemental medication
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Subject analysis set title
    SF 36
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    see https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    Primary: pain

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    End point title
    		 pain
    End point description
    see: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1
    End point type
    Primary
    End point timeframe
    described in manuscript (https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1)
    End point values
    		 CBDV Placebo
    Number of subjects analysed
    32
    32
    Units: https://medrxiv.org/cgi/content/short/20
    number (not applicable)
        https://medrxiv.org/cgi/content/short/2019.12.20.1
    32
    32
    Statistical analysis title
    		 Pain intensity
    Statistical analysis description
    Sample size was calculated by nQuery Advisor® 7.0 based on the primary endpoint (NRS scale) and the cross-over study-design. According to previous literature, a pain reduction by 20% upon verum compared to placebo and a common standard deviation (SD) for the period differences of 2.5 seemed to be achievable and would have been clinical meaningful
    Comparison groups
    CBDV v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05 [2]
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 1.51
    Variability estimate
    Standard deviation
    Dispersion value
    2.62
    Notes
    [1] - Sample size was calculated by nQuery Advisor® 7.0 based on the primary endpoint (NRS scale) and the cross-over study-design. According to previous literature, a pain reduction by 20% upon verum compared to placebo and a common standard deviation (SD) for the period differences of 2.5 seemed to be achievable and would have been clinical meaningful
    [2] - We calculated that 21 patients per sequence group were sufficient to show this effect (e.g. a reduction of 20% from 6 points to 4.8 points) with a power of 85% and a two-sided type-I-error of 0.05 using a paired t-test for 2x2 crossover designs

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    see: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2
    Frequency threshold for reporting non-serious adverse events: 5%
    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: justified in: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1

    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.
    see: https://medrxiv.org/cgi/content/short/2019.12.20.19015495v1
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