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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

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 baseline (screening) up to day 85

Summary

This trial is testing a new treatment called GWP42003-P for people with schizophrenia who aren't getting better with their current medications. The goal is to see if this new treatment is safe and effective.

Eligible Conditions
  • Schizophrenia

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Number of Participants With Suicidal Ideation or Behavior Based on The Columbia Suicide Severity Rating Scale (C-SSRS)

Side effects data

From 2016 Phase 3 trial • 225 Patients • NCT02224560
30%
Somnolence
26%
Decreased appetite
15%
Diarrhoea
12%
Upper respiratory tract infection
12%
Vomiting
11%
Pyrexia
11%
Nasopharyngitis
10%
Fatigue
6%
Headache
6%
Convulsion
6%
Lethargy
5%
Status epilepticus
5%
Insomnia
5%
Irritability
2%
Pneumonia
1%
Lymphopenia
1%
Constipation
1%
Pneumatosis intestinalis
1%
Adenovirus infection
1%
Pneumonia mycoplasmal
1%
Respiratory syncytial virus infection
1%
Delayed recovery from anaesthesia
1%
Aspartate aminotransferase increased
1%
Alanine aminotransferase increased
1%
Gamma-glutamyltransferase increased
1%
Pleural effusion
1%
Device malfunction
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set
Placebo-Safety Analysis Set
GWP42003-P 10 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
250 Previous Clinical Trials
34,879 Total Patients Enrolled
3 Trials studying Schizophrenia
98 Patients Enrolled for Schizophrenia
~18 spots leftby Dec 2025
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