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    Clinical Trial Results:
    A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study To Assess The Effect Of Cannabidiol (CBD) On Liver Fat Levels In Subjects With Fatty Liver Disease.

    Summary
    EudraCT number
    		 2009-017080-41
    Trial protocol
    		 GB  
    Global end of trial date
    13 Jul 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Oct 2018
    First version publication date
    03 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GWMD09112
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01284634
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GW Research Ltd
    Sponsor organisation address
    Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, United Kingdom, CB24 9BZ
    Public contact
    Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, medinfo@gwpharm.com
    Scientific contact
    Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, medinfo@gwpharm.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 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of GWP42003 on liver triglyceride levels (liver fat) in participants with fatty liver disease (FLD).
    Protection of trial subjects
    This study was conducted in accordance with International Council on Harmonisation Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted. No study procedures were performed on study candidates until written consent had been obtained from the participant. The informed consent form, protocol, and amendments for this study were submitted to and approved by an independent ethics committee.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2011
    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)
    22
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants had been clinically diagnosed with FLD, and had liver fat levels ≥5% as measured by Magnetic Resonance Imaging/ Magnetic Resonance Scanning (MRI/MRS) scanning, or a biopsy within two months prior to screening.

    Period 1
    Period 1 title
    Baseline, Treatment, and Follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    This study was partially-blinded. Due to the varying numbers of capsules to be administered, participants and investigators were not blinded to the treatment cohort (one, two or four capsules), but were blinded to the treatment allocation within each cohort (GWP42003 200, 400, or 800 milligrams [mg] or placebo).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GWP42003 200 mg/Day Dose
    Arm description
    		 Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003
    Investigational medicinal product code
    Other name
    Cannabidiol, CBD
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).

    Arm title
    		 GWP42003 400 mg/Day Dose
    Arm description
    		 Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003
    Investigational medicinal product code
    Other name
    Cannabidiol, CBD
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).

    Arm title
    		 GWP42003 800 mg/Day Dose
    Arm description
    		 Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003
    Investigational medicinal product code
    Other name
    Cannabidiol, CBD
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).

    Arm title
    		 Placebo
    Arm description
    		 Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo control
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14).

    Number of subjects in period 1
    		GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Started
    7
    6
    7
    5
    Received at least 1 dose of study drug
    7
    6
    7
    5
    Intent to Treat Analysis Set
    7
    6
    7
    5
    Safety Analysis Set
    7
    6
    7
    5
    Completed
    6
    6
    5
    4
    Not completed
    1
    0
    2
    1
         Adverse event, non-fatal
    1
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GWP42003 200 mg/Day Dose
    Reporting group description
    		 Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    GWP42003 400 mg/Day Dose
    Reporting group description
    		 Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    GWP42003 800 mg/Day Dose
    Reporting group description
    		 Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group values
    		 GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo Total
    Number of subjects
    		 7 6 7 5 25
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.69 ± 14.62 49.08 ± 7.72 46.90 ± 12.57 50.41 ± 18.41 -
    Gender categorical
    Units: Subjects
        Female
    		 5 2 2 4 13
        Male
    		 2 4 5 1 12

    End points

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    End points reporting groups
    Reporting group title
    GWP42003 200 mg/Day Dose
    Reporting group description
    		 Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    GWP42003 400 mg/Day Dose
    Reporting group description
    		 Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    GWP42003 800 mg/Day Dose
    Reporting group description
    		 Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Primary: Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels

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    End point title
    		 Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels
    End point description
    Liver triglyceride levels were measured by MRI/MRS scanning and the percent change from baseline to the EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
    End point type
    Primary
    End point timeframe
    Baseline to EOT (Day 57) or Early Termination (ET)
    End point values
    		 GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Number of subjects analysed
    7
    6
    6
    5
    Units: percent change
        arithmetic mean (standard deviation)
    -0.68 ± 4.97
    -0.28 ± 8.60
    0.65 ± 5.28
    6.36 ± 17.97
    Statistical analysis title
    		 % Change From BL In Mean Liver Triglyceride Levels
    Statistical analysis description
    All participants who were randomized, received at least one dose of study medication and had on-treatment efficacy data were included in the ITT analysis set. The EOT liver triglyceride levels were analysed using a linear regression model, with EOT triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
    Comparison groups
    GWP42003 200 mg/Day Dose v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.222
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -6.89
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -16.35
         upper limit
    		 2.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.454
    Statistical analysis title
    		 % Change from BL In Mean Liver Triglyceride Levels
    Statistical analysis description
    All participants who were randomized, received at least one dose of study medication and had on-treatment efficacy data were included in the ITT analysis set. The EOT liver triglyceride levels were analysed using a linear regression model, with EOT triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
    Comparison groups
    GWP42003 400 mg/Day Dose v Placebo
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.133
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -19.66
         upper limit
    		 0.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.943
    Statistical analysis title
    		 % Change From BL In Mean Liver Triglyceride Levels
    Statistical analysis description
    All participants who were randomized, received at least one dose of study medication and had on-treatment efficacy data were included in the ITT analysis set. The EOT liver triglyceride levels were analysed using a linear regression model, with EOT triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
    Comparison groups
    GWP42003 800 mg/Day Dose v Placebo
    Number of subjects included in analysis
    11
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.302
    Method
    		 Regression, Linear
    Parameter type
    		 Median difference (final values)
    Point estimate
    -6.54
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -17.22
         upper limit
    		 4.14
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.158

    Secondary: Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels

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    End point title
    		 Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels
    End point description
    A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
    End point type
    Secondary
    End point timeframe
    Baseline to EOT (Day 57) or ET
    End point values
    		 GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Number of subjects analysed
    7
    6
    7
    5
    Units: Millimole (mmol)/Litre (L )
        arithmetic mean (standard deviation)
    0.07 ± 0.76
    0.03 ± 0.51
    -0.14 ± 0.31
    -0.62 ± 1.00
    No statistical analyses for this end point

    Secondary: Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol (C) Levels

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    End point title
    		 Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol (C) Levels
    End point description
    A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
    End point type
    Secondary
    End point timeframe
    Baseline to EOT (Day 57) or ET
    End point values
    		 GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Number of subjects analysed
    7
    6
    7
    5
    Units: mmol/L
        arithmetic mean (standard deviation)
    0.07 ± 0.15
    0.08 ± 0.15
    0.06 ± 0.17
    -0.14 ± 0.23
    No statistical analyses for this end point

    Secondary: Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-C Ratio

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    End point title
    		 Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-C Ratio
    End point description
    A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.
    End point type
    Secondary
    End point timeframe
    Baseline to EOT (Day 57) or ET
    End point values
    		 GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Number of subjects analysed
    7
    6
    7
    5
    Units: change in ratio
        arithmetic mean (standard deviation)
    -0.02 ± 0.13
    -0.00 ± 0.08
    0.03 ± 0.09
    0.01 ± 0.06
    No statistical analyses for this end point

    Secondary: Change From Baseline To The EOT In Mean Serum Triglyceride Levels

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    End point title
    		 Change From Baseline To The EOT In Mean Serum Triglyceride Levels
    End point description
    A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
    End point type
    Secondary
    End point timeframe
    Baseline to EOT (Day 57) or ET
    End point values
    		 GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Number of subjects analysed
    7
    6
    7
    5
    Units: mmol/L
        arithmetic mean (standard deviation)
    -0.40 ± 1.05
    -0.29 ± 0.82
    -0.50 ± 1.16
    -0.28 ± 0.39
    No statistical analyses for this end point

    Secondary: Change From Baseline To The EOT In Mean Serum LDL-C Levels

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    End point title
    		 Change From Baseline To The EOT In Mean Serum LDL-C Levels
    End point description
    A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
    End point type
    Secondary
    End point timeframe
    Baseline to EOT (Day 57) or ET
    End point values
    		 GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Number of subjects analysed
    7
    6
    7
    5
    Units: mmol/l
        arithmetic mean (standard deviation)
    0.11 ± 0.631
    0.08 ± 0.407
    0.00 ± 0.432
    -0.34 ± 0.737
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Day 77 (Safety Follow-up)
    Adverse event reporting additional description
    Safety analysis set: All correctly randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    GWP42003 200 milligrams (mg)/Day Dose
    Reporting group description
    		 Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    GWP42003 400 mg/Day Dose
    Reporting group description
    		 Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    GWP42003 800 mg/Day Dose
    Reporting group description
    		 Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).

    Serious adverse events
    		 GWP42003 200 milligrams (mg)/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GWP42003 200 milligrams (mg)/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
    5 / 6 (83.33%)
    7 / 7 (100.00%)
    5 / 5 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Product size issue
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Heart sounds abnormal
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    1
    Dysgeusia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    3 / 6 (50.00%)
    2 / 7 (28.57%)
    0 / 5 (0.00%)
         occurrences all number
    2
    3
    2
    0
    Lethargy
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Poor quality sleep
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Meniere's disease
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    1
    2
    Abnormal faeces
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Change of bowel habit
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Defaecation urgency
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    4 / 7 (57.14%)
    3 / 6 (50.00%)
    5 / 7 (71.43%)
    0 / 5 (0.00%)
         occurrences all number
    5
    6
    8
    0
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Eructation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Frequent bowel movements
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal hypermotility
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Dec 2010
    The protocol was updated to include use of MRI/MRS scanning in the study. Urine tetrahydrocannabinol testing procedures were also added.
    17 May 2011
    The screening period was increased to allow MRI/MRS scanning to determine eligibility of participants. One additional withdrawal criterion and flexibility on visit windows was introduced. Typographical errors were corrected.

    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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