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
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EudraCT number |
2019-003369-16 |
Trial protocol |
ES PL |
Global end of trial date |
16 Mar 2022
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Results information
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Results version number |
v1 |
This version publication date |
01 Apr 2023
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First version publication date |
01 Apr 2023
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GWAP19030
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04421456 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GW Research Ltd
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Sponsor organisation address |
Sovereign House, Vision Park, Histon, Cambridge, United Kingdom, CB24 9BZ
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Public contact |
Clinical Trial Disclosure & Transparency, GW Research Ltd, +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
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Scientific contact |
Clinical Trial Disclosure & Transparency, GW Research Ltd, +1 215-832-3750, ClinicalTrialDisclosure@JazzPharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Mar 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Mar 2022
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Was the trial ended prematurely? |
Yes
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General information about the trial
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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
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Aug 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 3
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Country: Number of subjects enrolled |
Spain: 2
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Country: Number of subjects enrolled |
United States: 52
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Country: Number of subjects enrolled |
Serbia: 20
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Worldwide total number of subjects |
77
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EEA total number of subjects |
5
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
77
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 77 participants who met all inclusion and no exclusion criteria 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
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Screening details |
Participants were randomized to treatment following a single-blind, 2-week Placebo Run-in Period. | ||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Oral dose of GWP42003-P 150 mg administered twice daily
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Oral dose of GWP42003-P 500 mg administered twice daily
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Oral dose of matched placebo
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Baseline characteristics reporting groups
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Reporting group title |
GWP42003-P 300 mg
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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
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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
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GWP42003-P 300 mg
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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
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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
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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. |
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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.
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End point type |
Primary
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End point timeframe |
Baseline up to Week 12
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Statistical analysis title |
GWP42003-P 300 mg vs Pooled placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 300 mg v Pooled Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||||||||||
P-value |
= 0.4528 | ||||||||||||||||||||
Method |
Mixed-effects repeated measures model | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-1.75
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-6.35 | ||||||||||||||||||||
upper limit |
2.84 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
2.33
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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. |
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Statistical analysis title |
GWP42003-P 1000 mg vs Pooled placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 1000 mg v Pooled Placebo
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Number of subjects included in analysis |
38
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Analysis specification |
Pre-specified
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Analysis type |
superiority [2] | ||||||||||||||||||||
P-value |
= 0.4226 | ||||||||||||||||||||
Method |
Mixed-effects repeated measures model | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-1.96
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-6.76 | ||||||||||||||||||||
upper limit |
2.85 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
2.44
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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. |
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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.
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End point type |
Primary
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End point timeframe |
Baseline up to Week 12
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Statistical analysis title |
GWP42003-P 300 mg vs Pooled Placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 300 mg v Pooled Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority [3] | ||||||||||||||||||||
P-value |
= 0.4479 | ||||||||||||||||||||
Method |
Mixed-effects repeated measures model | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-0.63
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-2.25 | ||||||||||||||||||||
upper limit |
1 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.83
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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. |
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Statistical analysis title |
GWP42003-P 1000 mg vs Pooled Placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 1000 mg v Pooled Placebo
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Number of subjects included in analysis |
38
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Analysis specification |
Pre-specified
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Analysis type |
superiority [4] | ||||||||||||||||||||
P-value |
= 0.1616 | ||||||||||||||||||||
Method |
Mixed-effects repeated measures model | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-1.22
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-2.92 | ||||||||||||||||||||
upper limit |
0.49 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.87
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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. |
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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.
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End point type |
Primary
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End point timeframe |
Baseline up to Week 12
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Statistical analysis title |
GWP42003-P 300 mg vs Pooled Placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 300 mg v Pooled Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority [5] | ||||||||||||||||||||
P-value |
= 0.6787 | ||||||||||||||||||||
Method |
Mixed-effects repeated measures model | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-0.31
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.8 | ||||||||||||||||||||
upper limit |
1.18 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.76
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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. |
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Statistical analysis title |
GWP42003-P 1000 mg vs Pooled Placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 1000 mg v Pooled Placebo
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Number of subjects included in analysis |
38
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Analysis specification |
Pre-specified
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Analysis type |
superiority [6] | ||||||||||||||||||||
P-value |
= 0.3351 | ||||||||||||||||||||
Method |
Mixed-effects repeated measures model | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
0.76
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Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.79 | ||||||||||||||||||||
upper limit |
2.3 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.78
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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. |
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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.
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End point type |
Primary
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End point timeframe |
Baseline up to Week 12
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Statistical analysis title |
GWP42003-P 300 mg vs Pooled Placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 300 mg v Pooled Placebo
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority [7] | ||||||||||||||||||||
P-value |
= 0.4504 | ||||||||||||||||||||
Method |
Mixed-effects repeated measures model | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-1.1
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Confidence interval |
|||||||||||||||||||||
level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-3.96 | ||||||||||||||||||||
upper limit |
1.76 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
1.45
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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. |
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Statistical analysis title |
GWP42003-P 1000 mg vs Pooled Placebo | ||||||||||||||||||||
Comparison groups |
GWP42003-P 1000 mg v Pooled Placebo
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Number of subjects included in analysis |
38
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Analysis specification |
Pre-specified
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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. |
|
|||||||||||||||||||||
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
|
||||||||||||||||||||
|
|||||||||||||||||||||
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. |
|
|||||||||||||||||||||
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
|
||||||||||||||||||||
|
|||||||||||||||||||||
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 |
|
|||||||||||||||||||||
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
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
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
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
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
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
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
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
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
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Mean Change From Baseline in Temperature | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Baseline up to Week 12
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||
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
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
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
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Treatment-emergent adverse events (TEAEs) 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
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||
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 | |||||||
|
|||||||
Limitations and caveats |
|||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |