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    Clinical Trial Results:
    A Double-blind, Randomized, Placebo-controlled, Parallel-group Trial of the Efficacy and Safety of Nabiximols Oromucosal Spray as Add-on Therapy in Patients With Spasticity Due to Multiple Sclerosis

    Summary
    EudraCT number
    		 2019-002623-14
    Trial protocol
    		 CZ   PL   GB   RO  
    Global end of trial date
    28 Feb 2023

    Results information
    Results version number
    		 v1
    This version publication date
    06 Mar 2024
    First version publication date
    06 Mar 2024
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GWSP18023
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04203498
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GW Pharma Ltd
    Sponsor organisation address
    Sovereign House, Vision Park, Histon, Cambridge, United Kingdom,
    Public contact
    Director pf Clinical Trial Disclosure & Transparency, GW Pharma Ltd, a Jazz Pharmaceuticals Inc. Company, +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
    Scientific contact
    Director pf Clinical Trial Disclosure & Transparency, GW Pharma Ltd, a Jazz Pharmaceuticals Inc. Company, +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
    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
    28 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to establish the efficacy of nabiximols relative to placebo in reducing spasm count as part of the presentation of spasticity when used as adjunctive therapy in patients with MS who have not achieved adequate relief from other antispasticity agents.
    Protection of trial subjects
    This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, the ICH Tripartite Guideline for GCP Topic E6(R2), the US Food and Drug Administration regulations relating to GCP and clinical trials, the EU Clinical Trials Directive, the EU GCP Directive, and other applicable laws and regulations. The protocol, protocol amendments, ICF, investigator brochure, and other relevant documents were submitted to an IRB/IEC by the investigator and reviewed and approved by the IRB/IEC before the study was initiated.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2020
    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
    Poland: 64
    Country: Number of subjects enrolled
    Czechia: 31
    Country: Number of subjects enrolled
    Romania: 12
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 31
    Worldwide total number of subjects
    139
    EEA total number of subjects
    107
    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)
    121
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 139 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at clinic centers in Czech Republic, Poland, Romania, United Kingdom. and United States; 137 participants received treatment.

    Pre-assignment
    Screening details
    		 Participants who provided written informed consent were screened for entry into the trial and a number of assessments/procedures were performed to confirm study eligibility.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nabiximols
    Arm description
    		 Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray, in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GW-1000-02
    Investigational medicinal product code
    Other name
    Nabiximols
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Self-administered as an oromucosal 1 spray/day (starting dose) and titrated to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment

    Arm title
    		 Placebo
    Arm description
    		 Patients randomized to receive placebo self-administered as an oromucosal spray, in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    Self-administered as an oromuscosal 1 spray/day (starting dose) and titrated to an optimized dose or to a maximum of 12 sprays/day over the first 14 days of treatment

    Number of subjects in period 1
    		Nabiximols Placebo
    Started
    69
    70
    Completed
    55
    66
    Not completed
    14
    4
         Withdrawal of patient consent
    7
    2
         Adverse event, non-fatal
    4
    1
         Decision by the investigator, GW, or authority
    -
    1
         Drug not dispensed due to endpoint error
    1
    -
         Did not receive IMP
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nabiximols
    Reporting group description
    		 Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray, in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomized to receive placebo self-administered as an oromucosal spray, in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.

    Reporting group values
    		 Nabiximols Placebo Total
    Number of subjects
    		 69 70 139
    Age categorical
    Units: Subjects
        <18 years
    		 0 0 0
        ≥18 years to <45 years
    		 14 15 29
        ≥45 years to <65 years
    		 46 46 92
        ≥65 years
    		 9 9 18
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.1 ( 10.4 ) 53.0 ( 10.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 52 96
        Male
    		 25 18 43
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 64 68 132
        Black or African American
    		 3 1 4
        Asian
    		 0 0 0
        American Indian or Alaska Native
    		 0 0 0
        Other
    		 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    Nabiximols
    Reporting group description
    		 Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray, in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomized to receive placebo self-administered as an oromucosal spray, in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.

    Primary: Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period

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    End point title
    		 Change in Average Daily Spasm Count From Baseline to Week 12 By 4-Week Period During the 12-Week Randomized Period
    End point description
    The change in the average daily spasm count was assessed compared to the baseline period.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    67
    70
    Units: daily spasm count
    least squares mean (standard error)
        Week 1 to 4
    -2.23 ( 0.412 )
    -1.62 ( 0.394 )
        Week 5 to 8
    -3.42 ( 0.607 )
    -2.62 ( 0.583 )
        Week 9 to 12
    -3.84 ( 0.689 )
    -3.11 ( 0.659 )
    Statistical analysis title
    		 Nabiximols (Week 9 to 12) vs Placebo
    Statistical analysis description
    Week 9 to 12 (primary outcome statistics)
    Comparison groups
    Nabiximols v Placebo
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4263
    Method
    		 Linear mixed model repeated measures
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.54
         upper limit
    		 1.08
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.914

    Secondary: Change in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score

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    End point title
    		 Change in Multiple Sclerosis Spasticity Scale (MSSS-88) Total Score
    End point description
    The MSSS-88 is a self-reported measure of the impact of spasticity (muscle stiffness and spasms) in MS. This 88-item scale captures the patient experience and impact of spasticity, including muscle stiffness, pain and discomfort, muscle spasms, effect on daily activities, ability to walk, body movement, patient feelings, and social functioning. Responses to individual questions can range from “1 - not at all bothered” to “4 - extremely bothered.” Scores are summed and higher scores indicate poor clinical outcome. Least square means are being reported.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    51
    54
    Units: unit on a scale
    least squares mean (standard error)
        Week 8
    -21.64 ( 5.775 )
    -26.11 ( 5.461 )
        Week 12
    -26.53 ( 5.807 )
    -23.18 ( 5.426 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Laboratory Test Values

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    End point title
    		 Change From Baseline in Clinical Laboratory Test Values
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    59
    62
    Units: 10^9 cells/liter
    arithmetic mean (standard deviation)
        Basophils
    -0.009 ( 0.030 )
    0.002 ( 0.037 )
        Eosinophils
    -0.007 ( 0.110 )
    0.006 ( 0.086 )
        Leukocytes
    0.146 ( 1.095 )
    0.139 ( 1.881 )
        Lymphocytes
    -0.056 ( 0.368 )
    0.009 ( 0.315 )
        Monocytes
    0 ( 0.120 )
    0.001 ( 0.126 )
        Neutrophils
    0.217 ( 1.004 )
    0.083 ( 1.788 )
        Platelets
    -0.085 ( 42.392 )
    5.290 ( 49.972 )
    No statistical analyses for this end point

    Secondary: Number of Patients Reporting Any Treatment-emergent Adverse Events

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    End point title
    		 Number of Patients Reporting Any Treatment-emergent Adverse Events
    End point description
    A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
    End point type
    Secondary
    End point timeframe
    From date of first dose of IMP up to 30 days after last dose, up to approximately 16 weeks
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    67
    70
    Units: patients
    47
    32
    No statistical analyses for this end point

    Secondary: Change From Baseline in Erythrocytes

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    End point title
    		 Change From Baseline in Erythrocytes
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    59
    62
    Units: 10^12 cells/liter
        arithmetic mean (standard deviation)
    0.010 ( 0.241 )
    -0.007 ( 0.251 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hemoglobin

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    End point title
    		 Change From Baseline in Hemoglobin
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    59
    62
    Units: g/dL
        arithmetic mean (standard deviation)
    -0.025 ( 0.735 )
    -0.021 ( 0.726 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin

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    End point title
    		 Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    59
    62
    Units: pg
        arithmetic mean (standard deviation)
    -0.156 ( 0.608 )
    -0.005 ( 0.881 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hematocrit Ratio

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    End point title
    		 Change From Baseline in Hematocrit Ratio
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    59
    62
    Units: ratio of packed cells to total volume
        arithmetic mean (standard deviation)
    -0.002 ( 0.025 )
    -0.002 ( 0.027 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Blood Pressure

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    End point title
    		 Change From Baseline in Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    60
    67
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic blood pressure
    -1.6 ( 10.95 )
    2.6 ( 11.31 )
        Diastolic blood pressure
    0.3 ( 8.20 )
    2.7 ( 13.38 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Heart Rate

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    End point title
    		 Change From Baseline in Heart Rate
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    60
    67
    Units: beats/minute
        arithmetic mean (standard deviation)
    2.5 ( 7.70 )
    0.4 ( 10.14 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Electrocardiogram Parameters

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    End point title
    		 Change From Baseline in Electrocardiogram Parameters
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    61
    67
    Units: msec
    arithmetic mean (standard deviation)
        PR interval, aggregate
    5.5 ( 20.51 )
    1.3 ( 21.05 )
        QRS duration
    1.9 ( 9.89 )
    -6.5 ( 37.08 )
        QTcB interval
    1.5 ( 29.58 )
    -2.4 ( 33.29 )
        QTcF interval
    2.9 ( 26.69 )
    -3.2 ( 32.40 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Weight

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    End point title
    		 Change from Baseline in Weight
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    59
    67
    Units: kg
        arithmetic mean (standard deviation)
    -0.338 ( 3.198 )
    -0.394 ( 3.578 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Electrocardiogram Pulse Rate

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    End point title
    		 Change From Baseline in Electrocardiogram Pulse Rate
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    61
    67
    Units: beats/min
        arithmetic mean (standard deviation)
    -2.6 ( 10.21 )
    0.5 ( 8.74 )
    No statistical analyses for this end point

    Secondary: Change in Body Mass Index

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    End point title
    		 Change in Body Mass Index
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    59
    67
    Units: kg/m^2
        arithmetic mean (standard deviation)
    -0.086 ( 1.052 )
    -0.159 ( 1.287 )
    No statistical analyses for this end point

    Secondary: Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)

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    End point title
    		 Number of Patients With Suicidal Ideation or Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)
    End point description
    The C-SSRS is a short questionnaire that is used to assess suicidal ideation (5 questions) and behavior (5 questions) since last patient visit. The questionnaire is completed by participants answering yes or no to each question.
    End point type
    Secondary
    End point timeframe
    Screening up to Week 12
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    67
    70
    Units: number of patients
        Screening: Ideation, Wish to be dead
    1
    1
        Screening: Ideation, Non-specific active thoughts
    1
    1
        Screening: Ideation, Active any method no intent
    0
    1
        Screening: Ideation, Active intent to act, no plan
    0
    0
        Screening: Ideation, Active specific plan/intent
    0
    0
        Screening: Behavior, Preparatory acts or behavior
    0
    0
        Screening: Behavior, Aborted attempt
    0
    0
        Screening: Behavior, Interrupted attempt
    0
    0
        Screening: Behavior, Actual attempt
    0
    1
        Screening: Behavior, Completed suicide
    0
    0
        Screening: Suicidal ideation or behavior
    1
    1
        Screening: Self-injurious behavior
    0
    0
        Baseline: Ideation, Wish to be dead
    0
    0
        Baseline: Ideation, Non-specific active thoughts
    0
    0
        Baseline: Ideation, Active any method no intent
    0
    0
        Baseline: Ideation, Active intent to act, no plan
    0
    0
        Baseline: Ideation, Active specific plan/intent
    0
    0
        Baseline: Behavior, Preparatory acts or behavior
    0
    0
        Baseline: Behavior, Aborted attempt
    0
    0
        Baseline: Behavior, Interrupted attempt
    0
    0
        Baseline: Behavior, Actual attempt
    0
    0
        Baseline: Behavior, Completed suicide
    0
    0
        Baseline: Suicidal ideation or behavior
    0
    0
        Baseline: Self-injurious behavior
    0
    0
        Week 2: Ideation, Wish to be dead
    1
    0
        Week 2: Ideation, Non-specific active thoughts
    0
    0
        Week 2: Ideation, Active any method no intent
    0
    0
        Week 2: Ideation, Active intent to act, no plan
    0
    0
        Week 2: Ideation, Active specific plan/intent
    0
    0
        Week 2: Behavior, Preparatory acts or behavior
    0
    0
        Week 2: Behavior, Aborted attempt
    0
    0
        Week 2: Behavior, Interrupted attempt
    0
    0
        Week 2: Behavior, Actual attempt
    0
    0
        Week 2: Behavior, Completed suicide
    0
    0
        Week 2: Suicidal ideation or behavior
    1
    0
        Week 2: Self-injurious behavior
    0
    0
        Week 4: Ideation, Wish to be dead
    0
    0
        Week 4: Ideation, Non-specific active thoughts
    0
    0
        Week 4: Ideation, Active any method no intent
    0
    0
        Week 4: Ideation, Active intent to act, no plan
    0
    0
        Week 4: Ideation, Active specific plan/intent
    0
    0
        Week 4: Behavior, Preparatory acts or behavior
    0
    0
        Week 4: Behavior, Aborted attempt
    0
    0
        Week 4: Behavior, Interrupted attempt
    0
    0
        Week 4: Behavior, Actual attempt
    0
    0
        Week 4: Behavior, Completed suicide
    0
    0
        Week 4: Suicidal ideation or behavior
    0
    0
        Week 4: Self-injurious behavior
    0
    0
        Week 8: Ideation, Wish to be dead
    0
    0
        Week 8: Ideation, Non-specific active thoughts
    0
    0
        Week 8: Ideation, Active any method no intent
    0
    0
        Week 8: Ideation, Active intent to act, no plan
    0
    0
        Week 8: Ideation, Active specific plan/intent
    0
    0
        Week 8: Behavior, Preparatory acts or behavior
    0
    0
        Week 8: Behavior, Aborted attempt
    0
    0
        Week 8: Behavior, Interrupted attempt
    0
    0
        Week 8: Behavior, Actual attempt
    0
    0
        Week 8: Behavior, Completed suicide
    0
    0
        Week 8: Suicidal ideation or behavior
    0
    0
        Week 8: Self-injurious behavior
    0
    0
        Week 12: Ideation, Wish to be dead
    0
    0
        Week 12: Ideation, Non-specific active thoughts
    0
    0
        Week 12: Ideation, Active any method no intent
    0
    0
        Week 12: Ideation, Active intent to act, no plan
    0
    0
        Week 12: Ideation, Active specific plan/intent
    0
    0
        Week 12: Behavior, Preparatory acts or behavior
    0
    0
        Week 12: Behavior, Aborted attempt
    0
    0
        Week 12: Behavior, Interrupted attempt
    0
    0
        Week 12: Behavior, Actual attempt
    0
    0
        Week 12: Behavior, Completed suicide
    0
    0
        Week 12: Suicidal ideation or behavior
    0
    0
        Week 12: Self-injurious behavior
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from baseline up to end of study, approximately 2 years 5 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomized to receive placebo self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.

    Reporting group title
    Nabiximols
    Reporting group description
    		 Patients randomized to receive GW-1000-2 (nabiximols) self-administered as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.

    Serious adverse events
    		 Placebo Nabiximols
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 70 (7.14%)
    3 / 67 (4.48%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 70 (2.86%)
    2 / 67 (2.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 67 (1.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 67 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Nabiximols
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 70 (27.14%)
    46 / 67 (68.66%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 70 (7.14%)
    14 / 67 (20.90%)
         occurrences all number
    8
    15
    Somnolence
         subjects affected / exposed
    2 / 70 (2.86%)
    7 / 67 (10.45%)
         occurrences all number
    2
    7
    Taste disorder
         subjects affected / exposed
    0 / 70 (0.00%)
    4 / 67 (5.97%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 70 (2.86%)
    8 / 67 (11.94%)
         occurrences all number
    3
    9
    Asthenia
         subjects affected / exposed
    2 / 70 (2.86%)
    4 / 67 (5.97%)
         occurrences all number
    2
    4
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 70 (0.00%)
    6 / 67 (8.96%)
         occurrences all number
    0
    8
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 70 (5.71%)
    3 / 67 (4.48%)
         occurrences all number
    5
    3
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 70 (5.71%)
    3 / 67 (4.48%)
         occurrences all number
    5
    3

    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
    28 Feb 2023
    The study was terminated based on a business decision by the Sponsor.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Study enrollment did not reach the planned number of participants (N=446). In the current analysis, a total of 139 participants were randomized and 137 received treatment.
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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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