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    Clinical Trial Results:
    Neurophysiological assessment of the effect of Sativex (THC/CBD oromucosal spray) as add-on to treat spasticity following stroke

    Summary
    EudraCT number
    		 2016-001034-10
    Trial protocol
    		 IT  
    Global end of trial date
    20 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Apr 2020
    First version publication date
    26 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SativexStroke
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 SativexStroke: SativexStroke
    Sponsors
    Sponsor organisation name
    IRCCS Ospedale Policlinico San Martino
    Sponsor organisation address
    Largo Rosanna Benzi 10, Genova, Italy, 16132
    Public contact
    UO Epidemiologia Clinica, IRCCS Ospedale Policlinico San Martino, +39 0105558477,
    Scientific contact
    UO Epidemiologia Clinica, IRCCS Ospedale Policlinico San Martino, +39 0105558477,
    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
    31 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess if Sativex is able to reduce spasticity in chronic stroke patients
    Protection of trial subjects
    N/A
    Background therapy
    		 Background therapy shall remain the same during the trial period. Other cannabinoid-derived compounds are not permitted.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2018
    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
    Italy: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    19
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Planned recruitment was 50 stroke survivors between May 2018 and May 2020 in Italy.

    Pre-assignment
    Screening details
    		 Stroke survivors with spasticity in at least one muscle segment (Modified Ashworth Scale of at least 1) will be screened. Botulinum toxin treatment washout of at least 4 months is required, while concomitant antispastic drugs can be continued keeping dosage unaltered throughout the trial period.

    Period 1
    Period 1 title
    Phase 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All subjects will be treated with both active drug and placebo with a crossover design.

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Sativex, crossover phase 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Transmucosal use
    Dosage and administration details
    Oromucosal self administration with gradual increase up to 12 sprays/day

    Number of subjects in period 1
    		Experimental
    Started
    41
    Completed
    37
    Not completed
    4
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    2
    Period 2
    Period 2 title
    Phase 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 Experimental 2
    Arm description
    		 Sativex, crossover second phase
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Transmucosal use
    Dosage and administration details
    Oromucosal self administration with gradual increase up to 12 sprays/day

    Number of subjects in period 2
    		Experimental 2
    Started
    37
    Completed
    34
    Not completed
    3
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 1
    Reporting group description
    		 41 stroke survivors were recruited

    Reporting group values
    		 Phase 1 Total
    Number of subjects
    		 41 41
    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)
    		 19 19
        From 65-84 years
    		 22 22
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 31 31
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    94 patients were screened, 41 signed informed consent and started the trial

    Subject analysis sets values
    		 Intention-to-treat
    Number of subjects
    41
    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)
    19
        From 65-84 years
    22
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    31

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Sativex, crossover phase 1
    Reporting group title
    Experimental 2
    Reporting group description
    		 Sativex, crossover second phase

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    94 patients were screened, 41 signed informed consent and started the trial

    Primary: Spasticity assessment

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    End point title
    		 Spasticity assessment
    End point description
    The co-primary endpoints of the study will be to assess the effect of the tested treatment on muscle spasticity assessed with the stretch reflex and the 0-10 numeric rating scale for spasticity (NRS)
    End point type
    Primary
    End point timeframe
    Primary endpoint ware assessed 4 times: at baseline (T0), at the end of phase 1 (T1), at the beginning of phase 2 (T2) and at the end of phase 2 (T3)
    End point values
    		 Experimental Experimental 2
    Number of subjects analysed
    37
    34
    Units: Numeric rating scale
    37
    34
    Statistical analysis title
    		 Primary endpoints analysis
    Statistical analysis description
    Primary endpoints will be compared between phase 1 baseline (T0) versus phase 1 end (T1) and phase 2 baseline (T2) versus phase 2 end (T3) with respect to experimental/placebo conditions. Quantitative endpoint (stretch reflex) will be compared using a paired t-test. Semi-quantitative data (NRS) will be compared using a non-parametric test (Wilcoxon signed rank)
    Comparison groups
    Experimental v Experimental 2
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Notes
    [1] - In a crossover design patients taking active drug in period 1 are compared to placebo in period 2 and viceversa

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study period (about 2 and a half months per patient)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group title
    Period 2
    Reporting group description
    		 -

    Serious adverse events
    		 Period 1 Period 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 37 (5.41%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Seizure
    Additional description: First epileptic seizure (probably unrelated to study drug)
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Period 1 Period 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 41 (48.78%)
    21 / 37 (56.76%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    8 / 41 (19.51%)
    10 / 37 (27.03%)
         occurrences all number
    8
    10
    Balance disorder
         subjects affected / exposed
    4 / 41 (9.76%)
    8 / 37 (21.62%)
         occurrences all number
    4
    8
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 37 (10.81%)
         occurrences all number
    2
    4

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28882919
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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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