Trial Outcomes & Findings for 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 (NCT NCT04421456)

Last Updated: 2023-06-15

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

95 participants

Primary outcome timeframe

Baseline up to Week 12

Results posted on

2023-06-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	GWP42003-P 300 mg 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.	GWP42003-P 1000 mg 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.	Pooled Placebo Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Randomized Placebo Run-in Period STARTED	0	0	95
Randomized Placebo Run-in Period COMPLETED	0	0	77
Randomized Placebo Run-in Period NOT COMPLETED	0	0	18
Randomized Treatment Period STARTED	27	24	26
Randomized Treatment Period COMPLETED	23	19	19
Randomized Treatment Period NOT COMPLETED	4	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	GWP42003-P 300 mg 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.	GWP42003-P 1000 mg 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.	Pooled Placebo Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Randomized Placebo Run-in Period Placebo Run-in Failures	0	0	18
Randomized Treatment Period Adverse Event	0	1	0
Randomized Treatment Period Withdrawal of parent/legal representative consent	1	0	1
Randomized Treatment Period Lost to Follow-up	2	2	1
Randomized Treatment Period Participant non-compliance	1	1	2
Randomized Treatment Period Other	0	1	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GWP42003-P 300 mg n=27 Participants 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.	GWP42003-P 1000 mg n=24 Participants 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.	Pooled Placebo n=26 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.	Total n=77 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	77 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	37.5 years STANDARD_DEVIATION 7.53 • n=5 Participants	39.2 years STANDARD_DEVIATION 8.21 • n=7 Participants	38.7 years STANDARD_DEVIATION 8.87 • n=5 Participants	38.4 years STANDARD_DEVIATION 8.13 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	20 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	28 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	46 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	14 participants n=7 Participants	18 participants n=5 Participants	52 participants n=4 Participants
Region of Enrollment Poland	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Serbia	6 participants n=5 Participants	8 participants n=7 Participants	6 participants n=5 Participants	20 participants n=4 Participants
Region of Enrollment Spain	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Least Square Mean Change From Baseline in the Positive and Negative Symptoms Scale (PANSS) Total (PANSS-T) Score	-10.49 units on a scale Standard Error 1.64	-10.69 units on a scale Standard Error 1.75	-8.74 units on a scale Standard Error 1.78

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

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.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Least Square Mean Change From Baseline in the PANSS Positive Subscale (PANSS-P) Score	-3.16 units on a scale Standard Deviation 0.59	-3.75 units on a scale Standard Deviation 0.63	-2.53 units on a scale Standard Deviation 0.62

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

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.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score	-2.64 units on a scale Standard Deviation 0.53	-1.57 units on a scale Standard Deviation 0.56	-2.33 units on a scale Standard Deviation 0.58

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: Efficacy outcomes were assessed in the Full Analysis Set in participants with available data.

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.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score	-4.78 units on a scale Standard Deviation 1.03	-4.91 units on a scale Standard Deviation 1.10	-3.68 units on a scale Standard Deviation 1.09

PRIMARY outcome

Timeframe: Baseline up to Week 12

Population: Efficacy outcomes were assessed in the Full Analysis Set.

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.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score	-0.47 units on a scale Standard Deviation 0.11	-0.50 units on a scale Standard Deviation 0.12	-0.45 units on a scale Standard Deviation 0.12

PRIMARY outcome

Timeframe: Week 12

Population: Clinical Global Impression of Improvement (CGI-I) Score was assessed in the Full Analysis Set in participants with available data.

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.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Number of Participants With Minimally or Better Clinical Global Impression of Improvement (CGI-I) Score at Week 12	17 Participants	12 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Body weight was assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Mean Change From Baseline in Body Weight	-0.03 kilogram Standard Deviation 3.09	-0.14 kilogram Standard Deviation 1.98	1.37 kilogram Standard Deviation 1.28

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Body mass index was assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Mean Change From Baseline in Body Mass Index (BMI)	0 kg/m^2 Standard Deviation 0.98	-0.04 kg/m^2 Standard Deviation 0.66	0.45 kg/m^2 Standard Deviation 0.45

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Waist circumference was assessed in the Safety Analysis set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Mean Change From Baseline in Waist Circumference	0.41 centimeters Standard Deviation 5.36	-0.53 centimeters Standard Deviation 2.07	1.34 centimeters Standard Deviation 3.13

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Blood pressure was assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Mean Change From Baseline in Blood Pressure Diastolic blood pressure	1.7 mmHg Standard Deviation 6.19	0 mmHg Standard Deviation 7.05	-0.2 mmHg Standard Deviation 5.71
Mean Change From Baseline in Blood Pressure Systolic blood pressure	0.3 mmHg Standard Deviation 9.38	0 mmHg Standard Deviation 8.41	0.3 mmHg Standard Deviation 5.66

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Heart rate was assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Mean Change From Baseline in Heart Rate	1.0 beats/minute Standard Deviation 8.46	-3.1 beats/minute Standard Deviation 9.13	0.1 beats/minute Standard Deviation 6.52

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Respiratory rate was assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Mean Change From Baseline in Respiratory Rate	-0.6 breaths/minute Standard Deviation 2.13	0.1 breaths/minute Standard Deviation 1.37	0 breaths/minute Standard Deviation 1.45

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: Temperature was assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Mean Change From Baseline in Temperature	-0.07 Celsius Standard Deviation 0.34	0.06 Celsius Standard Deviation 0.20	-0.02 Celsius Standard Deviation 0.19

SECONDARY outcome

Timeframe: Day 85

Population: Clinically significant changes from baseline in vital signs were assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=23 Participants 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.	GWP42003-P 1000 mg n=19 Participants 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.	Pooled Placebo n=19 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Supine systolic blood pressure, Day 85: >20	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Supine diastolic blood pressure, Day 85: <-10	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Supine diastolic blood pressure, Day 85: >10	2 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Heart rate, Day 85: <-20	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Supine systolic blood pressure, Day 85: <-20	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Heart rate, Day 85: >20	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Weight, Day 85: ≤-7%	2 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Test Results Weight, Day 85: ≥7%	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 85

Population: Defined flagged ECG values were assessed in the Safety Analysis Set in participants with available data.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=27 Participants 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.	GWP42003-P 1000 mg n=24 Participants 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.	Pooled Placebo n=26 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values QTcF interval, Day 85: >450 msec	0 Participants	1 Participants	0 Participants
Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values QTcF interval, Day 85: >480 msec	0 Participants	0 Participants	0 Participants
Number of Participants With Defined Flagged Electrocardiogram (ECG) Parameter Values QTcF interval, Day 85: >500 msec	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (screening) up to Day 85

Population: Suicidal ideation and behavior was assessed in the Safety Analysis Set.

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.

Outcome measures

Outcome measures
Measure	GWP42003-P 300 mg n=24 Participants 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.	GWP42003-P 1000 mg n=27 Participants 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.	Pooled Placebo n=26 Participants Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal ideation, Non-specific active suicidal thoughts	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal behavior, Actual attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal behavior, Preparatory acts or behavior	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal behavior, Aborted attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal ideation, Active with any methods (not planned) without intent to act	0 Participants	1 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal ideation, Active with specific plan and intent	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal behavior, Interrupted attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal behavior, Actual attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal behavior, Completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal ideation, Wish to be dead	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal ideation, Non-specific active suicidal thoughts	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal ideation, Active with any methods (not planned) without intent to act	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal ideation, Active with some intent to act, without specific plan	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal ideation, Active with specific plan and intent	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal behavior, Preparatory acts or behavior	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal behavior, Aborted attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal behavior, Interrupted attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal behavior, Actual attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 85, Suicidal behavior, Completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal ideation, Wish to be dead	1 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal ideation, Active with any methods (not planned) without intent to act	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal ideation, Active with some intent to act, without specific plan	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal ideation, Active with specific plan and intent	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal behavior, Preparatory acts or behavior	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal behavior, Aborted attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal behavior, Interrupted attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Screening, Suicidal behavior, Completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal ideation, Wish to be dead	0 Participants	1 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal ideation, Non-specific active suicidal thoughts	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal ideation, Active with any methods (not planned) without intent to act	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal ideation, Active with some intent to act, without specific plan	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal ideation, Active with specific plan and intent	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal behavior, Interrupted attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal behavior, Actual attempt	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 14, Suicidal behavior, Completed suicide	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal ideation, Wish to be dead	1 Participants	1 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal ideation, Non-specific active suicidal thoughts	0 Participants	1 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal ideation, Active with some intent to act, without specific plan	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal behavior, Preparatory acts or behavior	0 Participants	0 Participants	0 Participants
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS) Day 29, Suicidal behavior, Aborted attempt	0 Participants	0 Participants	0 Participants

Adverse Events

GWP42003-P 300 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

GWP42003-P 1000 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Pooled Placebo (Treatment Period)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Pooled Placebo (Placebo Run-In Period)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GWP42003-P 300 mg n=27 participants at risk 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.	GWP42003-P 1000 mg n=24 participants at risk 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.	Pooled Placebo (Treatment Period) n=26 participants at risk Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.	Pooled Placebo (Placebo Run-In Period) n=95 participants at risk 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).
Infections and infestations COVID-19	7.4% 2/27 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/24 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/26 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/95 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.
Infections and infestations Coronavirus infection	0.00% 0/27 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	4.2% 1/24 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/26 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/95 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/27 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	4.2% 1/24 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/26 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/95 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.
Surgical and medical procedures Hospitalization	0.00% 0/27 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/24 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	3.8% 1/26 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/95 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.

Other adverse events

Other adverse events
Measure	GWP42003-P 300 mg n=27 participants at risk 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.	GWP42003-P 1000 mg n=24 participants at risk 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.	Pooled Placebo (Treatment Period) n=26 participants at risk Clinically stable schizophrenia participants experiencing inadequate response to antipsychotic treatment who were randomized to receive a matching placebo per day for 12 weeks.	Pooled Placebo (Placebo Run-In Period) n=95 participants at risk 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).
Infections and infestations COVID-19	7.4% 2/27 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/24 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/26 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/95 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.
Nervous system disorders Headache	3.7% 1/27 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	12.5% 3/24 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	11.5% 3/26 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.	0.00% 0/95 • All adverse events (AEs) were collected from baseline up to end of study, approximately 1 year 8 months.

Additional Information

Clinical Trial Disclosure & Transparency

Jazz Pharmaceuticals

Phone: 215-832-3750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place