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GWP42003-P for Schizophrenia

Phase 2
Waitlist Available
Research Sponsored by GW Research Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 85
Awards & highlights

Study Summary

This trial will test whether GWP42003-P is more effective than placebo at treating symptoms in people with schizophrenia who haven't responded well to other antipsychotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Least Square Mean Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Score
Least Square Mean Change From Baseline in the PANSS General Subscale (PANSS-G) Score
Least Square Mean Change From Baseline in the PANSS Negative Subscale (PANSS-N) Score
+3 more
Secondary outcome measures
Mean Change From Baseline in Blood Pressure
Mean Change From Baseline in Body Mass Index (BMI)
Mean Change From Baseline in Body Weight
+7 more

Side effects data

From 2016 Phase 3 trial • 225 Patients • NCT02224560
21%
Somnolence
16%
Decreased appetite
16%
Upper respiratory tract infection
10%
Status epilepticus
10%
Diarrhoea
9%
Pyrexia
9%
Irritability
7%
Fatigue
6%
Insomnia
6%
Vomiting
4%
Nasopharyngitis
4%
Pneumonia
4%
Lethargy
3%
Convulsion
3%
Headache
1%
Sedation
1%
Hypoventilation
1%
Cholecystitis chronic
1%
Sleep apnoea syndrome
1%
Dehydration
1%
Aspartate aminotransferase increased
1%
Transaminases increased
1%
Pancreatitis
1%
Pneumonia bacterial
1%
Pneumonia respiratory syncytial viral
1%
Hypoxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo-Safety Analysis Set
GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set
GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: GWP42003-P 300 mgExperimental Treatment1 Intervention
GWP42003-P 300 milligrams (mg) per day
Group II: GWP42003-P 1000 mgExperimental Treatment1 Intervention
GWP42003-P 1000 mg per day
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GWP42003-P
2016
Completed Phase 3
~1740

Find a Location

Who is running the clinical trial?

GW Research LtdLead Sponsor
35 Previous Clinical Trials
3,130 Total Patients Enrolled
2 Trials studying Schizophrenia
90 Patients Enrolled for Schizophrenia
Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,808 Total Patients Enrolled
3 Trials studying Schizophrenia
98 Patients Enrolled for Schizophrenia
~20 spots leftby Jul 2025
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