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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Patients with Multiple Sclerosis

    Summary
    EudraCT number
    		 2020-003271-18
    Trial protocol
    		 CZ   ES  
    Global end of trial date
    11 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Nov 2023
    First version publication date
    25 Nov 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GWSP20105
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04984278
    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 Clinical Trial Disclosure & Transparency, GW Pharma Ltd, a Jazz Pharmaceuticals Inc. Company, 1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
    Scientific contact
    Director 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
    11 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6; LLMT-6) in patients with MS
    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
    16 Aug 2021
    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: 15
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Czechia: 13
    Worldwide total number of subjects
    31
    EEA total number of subjects
    30
    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)
    28
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 31 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment at 7 clinic centers in Poland, Czech Republic, Spain, and United Kingdom.

    Pre-assignment
    Screening details
    		 After signing the ICF, participants with spasticity associated with MS participated in a Screening Period of up to 28 days; changes in the dosing regimen of the participants’ current MS antispasticity medications, if any, were not made during this period.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Nabiximols First, Then Placebo
    Arm description
    		 Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).
    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 spray for 21 days

    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 oromucosal spray for 21 days

    Arm title
    		 Placebo First, Then Nabiximols
    Arm description
    		 Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 31; Treatment Period 2).
    Arm type
    		 Experimental

    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 oromucosal spray for 21 days

    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 spray for 21 days

    Number of subjects in period 1
    		Nabiximols First, Then Placebo Placebo First, Then Nabiximols
    Started
    16
    15
    Completed
    15
    14
    Not completed
    1
    1
         Not specified
    -
    1
         Withdrawal by subject
    1
    -
    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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nabiximols First, Then Placebo
    Arm description
    		 Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).
    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 spray for 21 days

    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 oromucosal spray for 21 days

    Arm title
    		 Placebo First, Then Nabiximols
    Arm description
    		 Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 31; Treatment Period 2).
    Arm type
    		 Experimental

    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 oromucosal spray for 21 days

    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 spray for 21 days

    Number of subjects in period 2
    		Nabiximols First, Then Placebo Placebo First, Then Nabiximols
    Started
    15
    14
    Completed
    14
    13
    Not completed
    1
    1
         Adverse event, non-fatal
    1
    -
         Not specified
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nabiximols First, Then Placebo
    Reporting group description
    		 Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).

    Reporting group title
    Placebo First, Then Nabiximols
    Reporting group description
    		 Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 31; Treatment Period 2).

    Reporting group values
    		 Nabiximols First, Then Placebo Placebo First, Then Nabiximols Total
    Number of subjects
    		 16 15 31
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 14 14 28
        From 65-84 years
    		 2 1 3
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.5 ( 10.3 ) 48.8 ( 7.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 9 19
        Male
    		 6 6 12

    End points

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    End points reporting groups
    Reporting group title
    Nabiximols First, Then Placebo
    Reporting group description
    		 Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).

    Reporting group title
    Placebo First, Then Nabiximols
    Reporting group description
    		 Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 31; Treatment Period 2).
    Reporting group title
    Nabiximols First, Then Placebo
    Reporting group description
    		 Participants who were randomized to receive GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received matching placebo treatment for 21 days (starting at Day 31; Treatment Period 2).

    Reporting group title
    Placebo First, Then Nabiximols
    Reporting group description
    		 Participants who were randomized to receive matching placebo self-administered for 21 days (starting on Day 1; Treatment Period 1), followed by at least a 7-day wash out period, and then received GW-1000-02 (nabiximols) self-administered as an oromucosal spray for 21 days (starting on Day 31; Treatment Period 2).

    Subject analysis set title
    Nabiximols
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).

    Subject analysis set title
    Nabiximols
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).

    Primary: Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)

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    End point title
    		 Change From Baseline in Lower Limb Muscle Tone-6 (LLMT-6)
    End point description
    LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.
    End point type
    Primary
    End point timeframe
    Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    16
    15
    Units: units on a scale
    least squares mean (standard error)
        LLMT-6
    -0.32 ( 0.072 )
    -0.04 ( 0.075 )
    Statistical analysis title
    		 Change From Baseline in LLMT-6
    Comparison groups
    Nabiximols v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0048
    Method
    		 Mixed models analysis
    Parameter type
    		 Combined least mean square difference
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.092

    Secondary: Change From Baseline in Lower Limb Muscle Tone-4 (LLMT-4)

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    End point title
    		 Change From Baseline in Lower Limb Muscle Tone-4 (LLMT-4)
    End point description
    LLMT-4 is defined as the average of the 4 individual MAS transformed scores of knee flexors and knee extensors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-4 score is being reported. Negative values indicate an improvement in muscle tone.
    End point type
    Secondary
    End point timeframe
    Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    16
    15
    Units: units on a scale
    least squares mean (standard error)
        LLMT-4
    -0.34 ( 0.079 )
    -0.09 ( 0.082 )
    No statistical analyses for this end point

    Secondary: Number of Patients With Any Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Patients With Any Treatment-emergent Adverse Events (TEAEs)
    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
    Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    30
    30
    Units: patients
    number (not applicable)
        Any TEAE
    19
    6
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    29
    27
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic blood pressure
    -2.5 ( 11.27 )
    -4.4 ( 8.26 )
        Diastolic blood pressure
    -1.9 ( 7.74 )
    -2.8 ( 7.66 )
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    29
    27
    Units: beats/minute
    arithmetic mean (standard deviation)
        Heart rate
    0.9 ( 8.97 )
    -0.1 ( 9.13 )
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    27 [1]
    25 [2]
    Units: 10^9 cells per liter
    arithmetic mean (standard deviation)
        Leukocytes
    0 ( 1.68 )
    -0.07 ( 1.94 )
        Neutrophils
    0.071 ( 0.94 )
    -0.399 ( 0.53 )
        Basophils
    -0.01 ( 0.07 )
    0 ( 0.07 )
        Eosinophils
    0.04 ( 0.22 )
    0.04 ( 0.19 )
        Lymphocytes
    -0.041 ( 0.48 )
    0.033 ( 0.48 )
        Monocytes
    0.01 ( 0.22 )
    0.03 ( 0.20 )
        Platelets
    2.4 ( 23.20 )
    4.6 ( 25.91 )
    Notes
    [1] - Except neutrophils, n=15
    [2] - Except neutrophils, n=12
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    27
    27
    Units: 10^12 cells per liter
    arithmetic mean (standard deviation)
        Erythrocytes
    -0.138 ( 0.20 )
    -0.09 ( 0.19 )
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    27
    25
    Units: g/dL
    arithmetic mean (standard deviation)
        Hemoglobin
    -0.34 ( 0.62 )
    -0.21 ( 0.53 )
    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
    Hematocrit was measured in whole blood samples. The ratio of packed cells to total volume was assessed. Normal ratio ranges from 0.350–0.470 female and 0.400–0.540 male (normal ranges per our central lab), 0.37 (or 37%) to 0.52 (or 52%) in adults. Lower hematocrit ratios indicate worse clinical outcome.
    End point type
    Secondary
    End point timeframe
    Baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    27
    25
    Units: ratio of packed cells to total volume
    arithmetic mean (standard deviation)
        Hematocrit ratio
    -0.012 ( 0.0191 )
    -0.009 ( 0.0191 )
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    27
    25
    Units: pg
    arithmetic mean (standard deviation)
        Erythrocyte mean corpuscular hemoglobin
    0.1 ( 0.64 )
    0.1 ( 0.57 )
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    29
    27
    Units: msec
    arithmetic mean (standard deviation)
        PR duration
    -3.1 ( 27.35 )
    0.5 ( 26.78 )
        QRS duration
    2.0 ( 6.10 )
    1.7 ( 5.54 )
        QT interval
    5.4 ( 15.35 )
    4.0 ( 17.79 )
        QTcB interval
    -0.8 ( 16.04 )
    4.9 ( 15.20 )
        QTcF interval
    2.5 ( 12.60 )
    5.2 ( 13.84 )
    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 (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2)
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    29
    27
    Units: beats/minute
    arithmetic mean (standard deviation)
        Electrocardiogram pulse rate
    -2.0 ( 9.42 )
    -0.1 ( 7.78 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)

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    End point title
    		 Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (CSSRS)
    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
    Baseline, Day 15, and Day 21
    End point values
    		 Nabiximols Placebo
    Number of subjects analysed
    30
    30
    Units: participants
    number (not applicable)
        Baseline: Ideation
    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
    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 (non-fatal)
    0
    0
        Baseline: Behavior, Completed suicide
    0
    0
        Baseline: Ideation or Behavior
    0
    0
        Baseline: Self-injurious behavior without intent
    0
    0
        Day 15: Ideation
    0
    1
        Day 15: Ideation, Wish to be dead
    0
    0
        Day 15: Ideation, Non-specific active thoughts
    0
    0
        Day 15: Ideation, Active any method no intent
    0
    1
        Day 15: Ideation, Active intent to act no plan
    0
    1
        Day 15: Ideation, Active specific plan/intent
    0
    0
        Day 15: Behavior
    0
    0
        Day 15: Behavior, Preparatory acts or behavior
    0
    0
        Day 15: Behavior, Aborted attempt
    0
    0
        Day 15: Behavior, Interrupted attempt
    0
    0
        Day 15: Behavior, Actual attempt (non-fatal)
    0
    0
        Day 15: Behavior, Completed suicide
    0
    0
        Day 15: Ideation or behavior
    0
    0
        Day 15: Self-injurious behavior without intent
    0
    0
        Day 21: Ideation
    0
    0
        Day 21: Ideation, Wish to be dead
    0
    0
        Day 21: Ideation, Non-specific active thoughts
    0
    0
        Day 21: Ideation, Active any method no intent
    0
    0
        Day 21: Ideation, Active intent to act no plan
    0
    0
        Day 21: Ideation, Active specific plan/intent
    0
    0
        Day 21: Behavior
    0
    0
        Day 21: Behavior, Preparatory acts or behavior
    0
    0
        Day 21: Behavior, Aborted attempt
    0
    0
        Day 21: Behavior, Interrupted attempt
    0
    0
        Day 21: Behavior, Actual attempt (non-fatal)
    0
    0
        Day 21: Behavior, Completed suicide
    0
    0
        Day 21: Ideation or behavior
    0
    0
        Day 21: Self-injurious behavior without intent
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse event (TEAE) data were collected from baseline (predose Day 1 of Treatment Period 1) up to Day 51 (end of treatment of Treatment Period 2).
    Adverse event reporting additional description
    A TEAE is an adverse event that started, or worsened in severity or seriousness, following the first dose of the investigational medicinal product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Nabiximols
    Reporting group description
    		 A 21-day treatment period with nabiximols self-administered as an oromucosal spray (without regard to treatment period).

    Reporting group title
    Placebo
    Reporting group description
    		 A 21-day treatment period with placebo self-administered as an oromucosal spray (without regard to treatment period).

    Serious adverse events
    		 Nabiximols Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nabiximols Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 30 (20.00%)
    0 / 30 (0.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 30 (0.00%)
         occurrences all number
    4
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0

    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
    11 Nov 2022
    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.
    None reported
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