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    Clinical Trial Results:
    A Randomized, Double-blind, Parallel-group Trial to Investigate the Safety and Efficacy of GWP42003-P Versus Placebo as Adjunctive Therapy in Participants with Schizophrenia Experiencing Inadequate Response to Ongoing Antipsychotic Treatment

    Summary
    EudraCT number
    		 2019-003369-16
    Trial protocol
    		 ES   PL  
    Global end of trial date
    16 Mar 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    09 Jul 2023
    First version publication date
    01 Apr 2023
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    New data were included in the Adverse Event section

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GWAP19030
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04421456
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GW Research Ltd
    Sponsor organisation address
    Sovereign House, Vision Park, Histon, Cambridge, United Kingdom, CB24 9BZ
    Public contact
    Clinical Trial Disclosure & Transparency, GW Research Ltd, +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
    Scientific contact
    Clinical Trial Disclosure & Transparency, GW Research Ltd, +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
    16 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To evaluate the efficacy of GWP42003 P versus placebo after 12 weeks of treatment • To evaluate the safety and tolerability of GWP42003 P
    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 Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for GCP E6(R2), the EU Clinical Trials Directive, the EU GCP Directive and the clinical study regulations adopting European Commission Directives into national legislation. The protocol, protocol amendments, informed consent form, Investigator's Brochure, and other relevant documents (eg, advertisements) were submitted to the Institutinal Review Board/Independent Ethics Committee (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
    18 Aug 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: 3
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United States: 68
    Country: Number of subjects enrolled
    Serbia: 21
    Worldwide total number of subjects
    95
    EEA total number of subjects
    6
    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)
    95
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 95 participants who met all inclusion and no exclusion criteria were enrolled in the study and were randomized to the Placebo Run-in Period. Eighteen participants failed the Placebo Run-in Period. A total of 77 participants were randomized to 1 of 2 GWP42003-P doses or placebo treatment at a 2:2:1:1 ratio at 33 clinic centers.

    Pre-assignment
    Screening details
    		 Once enrolled, participants were randomized to treatment following a single-blind, 2-week Placebo Run-in Period. A total of 95 participants were included the Placebo Run-in Period; 18 participants failed the Placebo Run-in Period. A total of 77 participants were randomized to the Treatment Period.

    Period 1
    Period 1 title
    Randomized Placebo Run-in Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Pooled Placebo
    Arm description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral dose of matched placebo

    Number of subjects in period 1
    		Pooled Placebo
    Started
    95
    Completed
    77
    Not completed
    18
         Placebo run-in failures
    18
    Period 2
    Period 2 title
    Randomized Treatment Period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GWP42003-P 300 mg
    Arm description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003-P
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral dose of GWP42003-P 150 mg administered twice daily

    Arm title
    		 GWP42003-P 1000 mg
    Arm description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GWP42003-P
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral dose of GWP42003-P 500 mg administered twice daily

    Arm title
    		 Pooled Placebo
    Arm description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Oral dose of matched placebo

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The baseline period is the Treatment Period where patients were randomized to either GWP42003-P (300 mg or 1000 mg) or placebo.
    Number of subjects in period 2 [2]
    		GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Started
    27
    24
    26
    Completed
    23
    19
    19
    Not completed
    4
    5
    7
         Withdrawal of parent/legal representative consent
    1
    -
    1
         Adverse event, non-fatal
    -
    1
    -
         Not specified
    -
    1
    3
         Lost to follow-up
    2
    2
    1
         Participant non-compliance
    1
    1
    2
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number of patients included 95 participants who were enrolled in the study and randomized to the Placebo Run-in Period. Eighteen participants failed the Placebo Run-in Period. Therefore, a total of 77 participants were randomized to the Treatment Period and is considered the baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GWP42003-P 300 mg
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.

    Reporting group title
    GWP42003-P 1000 mg
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

    Reporting group values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo Total
    Number of subjects
    		 27 24 26 77
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 27 24 26 77
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.5 ± 7.53 39.2 ± 8.21 38.7 ± 8.87 -
    Gender categorical
    Units: Subjects
        Female
    		 6 7 7 20
        Male
    		 21 17 19 57

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
    Reporting group title
    GWP42003-P 300 mg
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.

    Reporting group title
    GWP42003-P 1000 mg
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.

    Reporting group title
    Pooled Placebo
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

    Primary: Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale Total (PANSS-T) Score

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    End point title
    		 Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale Total (PANSS-T) Score
    End point description
    The PANSS-T is a medical scale used for measuring symptom severity of participants with schizophrenia or related psychotic disorder. It is a 30-item rating instrument that assesses the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. A PANSS-T score is derived from the sum of the 30 items and the total score ranges from 30 to 210, where higher scores represent worse outcome. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: units on a scale
    least squares mean (standard error)
        PANSS-T Score
    -10.49 ± 1.64
    -10.69 ± 1.75
    -8.74 ± 1.78
    Statistical analysis title
    		 GWP42003-P 300 mg vs Pooled placebo
    Comparison groups
    GWP42003-P 300 mg v Pooled Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.4528
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    -1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.35
         upper limit
    		 2.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.33
    Notes
    [1] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.
    Statistical analysis title
    		 GWP42003-P 1000 mg vs Pooled placebo
    Comparison groups
    GWP42003-P 1000 mg v Pooled Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.4226
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    -1.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.76
         upper limit
    		 2.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.44
    Notes
    [2] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.

    Primary: Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score

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    End point title
    		 Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score
    End point description
    The PANSS ‘P’ Scale was calculated as the sum of the items prefixed with an P, 7 items in total, i.e. delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: units on a scale
    least squares mean (standard error)
        PANSS-P Score
    -3.16 ± 0.59
    -3.75 ± 0.63
    -2.53 ± 0.62
    Statistical analysis title
    		 GWP42003-P 300 mg vs Pooled Placebo
    Comparison groups
    Pooled Placebo v GWP42003-P 300 mg
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.4479
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    -0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.25
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.83
    Notes
    [3] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.
    Statistical analysis title
    		 GWP42003-P 1000 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 1000 mg v Pooled Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.1616
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    -1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.92
         upper limit
    		 0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.87
    Notes
    [4] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.

    Primary: Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score

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    End point title
    		 Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score
    End point description
    The PANSS ‘N’ Scale will be calculated as the sum of the items prefixed with an N, 7 items in total, i.e. blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: units on a scale
    least squares mean (standard error)
        PANSS-N Score
    -2.64 ± 0.53
    -1.57 ± 0.56
    -2.33 ± 0.58
    Statistical analysis title
    		 GWP42003-P 300 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 300 mg v Pooled Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.6787
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    -0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 1.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.76
    Notes
    [5] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.
    Statistical analysis title
    		 GWP42003-P 1000 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 1000 mg v Pooled Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.3351
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 2.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.78
    Notes
    [6] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.

    Primary: Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score

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    End point title
    		 Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score
    End point description
    The PANSS ‘G’ Scale will be calculated as the sum of the items prefixed with a G, 16 items in total, i.e. somatic concerns, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. Individual items are rated on a 7-point scale, where 1 = absent and 7 = extreme. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: units on a scale
    least squares mean (standard error)
        PANSS-G Score
    -4.78 ± 1.03
    -4.91 ± 1.10
    -3.68 ± 1.09
    Statistical analysis title
    		 GWP42003-P 300 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 300 mg v Pooled Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.4504
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.96
         upper limit
    		 1.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.45
    Notes
    [7] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.
    Statistical analysis title
    		 GWP42003-P 1000 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 1000 mg v Pooled Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.4195
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    -1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.22
         upper limit
    		 1.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.52
    Notes
    [8] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.

    Primary: Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score

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    End point title
    		 Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score
    End point description
    The CGI-S is a 7-point scale used to rate the severity of participants’ illness at the time of assessment. Considering total clinical experience, a participant will be assessed on severity of mental illness at the time of rating 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = among the most extremely ill participants. The least square mean change from baseline is being reported and negative values indicate an improvement in outcome.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: units on a scale
    least squares mean (standard error)
        CGI-S Score
    -0.47 ± 0.11
    -0.50 ± 0.12
    -0.45 ± 0.12
    Statistical analysis title
    		 GWP42003-P 300 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 300 mg v Pooled Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.885
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Notes
    [9] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.
    Statistical analysis title
    		 GWP42003-P 1000 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 1000 mg v Pooled Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 = 0.7808
    Method
    		 Mixed-effects repeated measures model
    Parameter type
    		 Least square mean difference
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 0.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Notes
    [10] - The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.

    Primary: Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12

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    End point title
    		 Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12
    End point description
    The CGI-I is a 7-point scale used to rate the improvement of participants' condition at the time of assessment. Compared to the patient's condition at baseline, the participants' condition was rated as 1 = very much improved since initiation of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline; 5 = minimally worse; 6 = much worse; 7 = very much worse since the initiation of treatment. Higher scores indicate a worse outcome. The number of participants with minimally or better improvements (score of 3 or better) are being reported.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: number of participants
    number (not applicable)
        Minimally or Better CGI-I Score
    17
    12
    15
    Statistical analysis title
    		 GWP42003-P 300 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 300 mg v Pooled Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6707
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.412
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.288
         upper limit
    		 6.924
    Statistical analysis title
    		 GWP42003-P 1000 mg vs Pooled Placebo
    Comparison groups
    GWP42003-P 1000 mg v Pooled Placebo
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4883
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.576
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.121
         upper limit
    		 2.744

    Secondary: Mean Change From Baseline in Body Weight

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    End point title
    		 Mean Change From Baseline in Body Weight
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: kg
    arithmetic mean (standard deviation)
        Body weight
    -0.03 ± 3.09
    -0.14 ± 1.98
    1.37 ± 1.28
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Body Mass Index (BMI)

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    End point title
    		 Mean Change From Baseline in Body Mass Index (BMI)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: kg/m^2
    arithmetic mean (standard deviation)
        Body mass index
    0 ± 0.98
    -0.04 ± 0.66
    0.45 ± 0.45
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Waist Circumference

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    End point title
    		 Mean Change From Baseline in Waist Circumference
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: centimeters
    arithmetic mean (standard deviation)
        Waist circumference
    0.41 ± 5.36
    -0.53 ± 2.07
    1.34 ± 3.13
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Blood Pressure

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    End point title
    		 Mean Change From Baseline in Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: mmHg
    arithmetic mean (standard deviation)
        Diastolic blood pressure
    1.7 ± 6.19
    0 ± 7.05
    -0.2 ± 5.71
        Systolic blood pressure
    0.3 ± 9.38
    0 ± 8.41
    0.3 ± 5.66
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Heart Rate

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    End point title
    		 Mean Change From Baseline in Heart Rate
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: beats/minute
    arithmetic mean (standard deviation)
        Heart rate
    1.0 ± 8.46
    -3.1 ± 9.13
    0.1 ± 6.52
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Respiratory Rate

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    End point title
    		 Mean Change From Baseline in Respiratory Rate
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: breaths/minute
    arithmetic mean (standard deviation)
        Respiratory rate
    -0.6 ± 2.13
    0.1 ± 1.37
    0 ± 1.45
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Temperature

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    End point title
    		 Mean Change From Baseline in Temperature
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: Celsius
    arithmetic mean (standard deviation)
        Temperature
    -0.07 ± 0.34
    0.06 ± 0.20
    -0.02 ± 0.19
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results

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    End point title
    		 Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    23
    19
    19
    Units: number of participants
    number (not applicable)
        Supine systolic blood pressure, Day 85: <-20
    0
    0
    0
        Supine systolic blood pressure, Day 85: >20
    1
    0
    0
        Supine diastolic blood pressure, Day 85: <-10
    0
    1
    0
        Supine diastolic blood pressure, Day 85: >10
    2
    1
    0
        Heart rate, Day 85: <-20
    0
    0
    0
        Heart rate, Day 85: >20
    0
    0
    0
        Weight, Day 85: ≤-7%
    2
    1
    0
        Weight, Day 85: ≥7%
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values

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    End point title
    		 Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 12
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    27
    24
    26
    Units: number of participants
    number (not applicable)
        QTcF interval, Day 85: >450 msec
    0
    1
    0
        QTcF interval, Day 85: >480 msec
    0
    0
    0
        QTcF interval, Day 85: >500 msec
    0
    0
    0
    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 (screening) up to Day 85
    End point values
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo
    Number of subjects analysed
    27
    24
    26
    Units: number of participants
    number (not applicable)
        Screening: Ideation, Wish to be dead
    1
    0
    0
        Screening: Ideation, Non-specific active thoughts
    0
    0
    0
        Screening: Ideation, Active any method no intent
    0
    0
    0
        Screening: Ideation, Active intent to act, no plan
    0
    0
    0
        Screening: Ideation, Active specific plan/intent
    0
    0
    0
        Screening: Behavior, Preparatory acts or behavior
    0
    0
    0
        Screening: Behavior, Aborted attempt
    0
    0
    0
        Screening: Behavior, Interrupted attempt
    0
    0
    0
        Screening: Behavior, Actual attempt
    0
    0
    0
        Screening: Behavior, Completed suicide
    0
    0
    0
        Day 14: Ideation, Wish to be dead
    0
    1
    0
        Day 14: Ideation, Non-specific active thoughts
    0
    0
    0
        Day 14: Ideation, Active any method no intent
    0
    0
    0
        Day 14: Ideation, Active intent to act, no plan
    0
    0
    0
        Day 14: Ideation, Active specific plan/intent
    0
    0
    0
        Day 14: Behavior, Preparatory acts or behavior
    0
    0
    0
        Day 14: Behavior, Aborted attempt
    0
    0
    0
        Day 14: Behavior, Interrupted attempt
    0
    0
    0
        Day 14: Behavior, Actual attempt
    0
    0
    0
        Day 14: Behavior, Completed suicide
    0
    0
    0
        Day 29: Ideation, Wish to be dead
    1
    1
    0
        Day 29: Ideation, Non-specific active thoughts
    0
    1
    0
        Day 29: Ideation, Active any method no intent
    0
    1
    0
        Day 29: Ideation, Active intent to act, no plan
    0
    0
    0
        Day 29: Ideation, Active specific plan/intent
    0
    0
    0
        Day 29: Behavior, Preparatory acts or behavior
    0
    0
    0
        Day 29: Behavior, Aborted attempt
    0
    0
    0
        Day 29: Behavior, Interrupted attempt
    0
    0
    0
        Day 29: Behavior, Actual attempt
    0
    0
    0
        Day 29: Behavior, Completed suicide
    0
    0
    0
        Day 85: Ideation, Wish to be dead
    0
    0
    0
        Day 85: Ideation, Non-specific active thoughts
    0
    0
    0
        Day 85: Ideation, Active any method no intent
    0
    0
    0
        Day 85: Ideation, Active intent to act, no plan
    0
    0
    0
        Day 85: Ideation, Active specific plan/intent
    0
    0
    0
        Day 85: Behavior, Preparatory acts or behavior
    0
    0
    0
        Day 85: Behavior, Aborted attempt
    0
    0
    0
        Day 85: Behavior, Interrupted attempt
    0
    0
    0
        Day 85: Behavior, Actual attempt
    0
    0
    0
        Day 85: Behavior, Completed suicide
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    GWP42003-P 300 mg
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 300 milligrams (mg) per day for 12 weeks.

    Reporting group title
    GWP42003-P 1000 mg
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive an oral dose of GWP42003-P 1000 milligrams (mg) per day for 12 weeks.

    Reporting group title
    Pooled Placebo (Treatment Period)
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.

    Reporting group title
    Pooled Placebo (Placebo Run-in Period)
    Reporting group description
    		 Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo for 2 weeks (including participants who failed the placebo run-in period).

    Serious adverse events
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo (Treatment Period) Pooled Placebo (Placebo Run-in Period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 24 (8.33%)
    1 / 26 (3.85%)
    0 / 95 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Surgical and medical procedures
    Hospitalization
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 24 (0.00%)
    1 / 26 (3.85%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 24 (4.17%)
    0 / 26 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 24 (4.17%)
    0 / 26 (0.00%)
    0 / 95 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GWP42003-P 300 mg GWP42003-P 1000 mg Pooled Placebo (Treatment Period) Pooled Placebo (Placebo Run-in Period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 27 (11.11%)
    3 / 24 (12.50%)
    3 / 26 (11.54%)
    0 / 95 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 24 (12.50%)
    3 / 26 (11.54%)
    0 / 95 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 24 (0.00%)
    0 / 26 (0.00%)
    0 / 95 (0.00%)
         occurrences all number
    2
    0
    0
    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
    16 Mar 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
    For support, Contact us.
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