GWP42003-P for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder+3 More
GWP42003-P - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if GWP42003-P can help reduce symptoms in children with ASD.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Autism Spectrum Disorder

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Day 29; Day 85

Day 1; Day 85
Change from Day 1 in Vineland Adaptive Behavior Scales-3 (VABS-3) Scores
Day 29; Day 85
Change from Day 29 in Clinical Global Impression Improvement (CGI-I) Scores
Screening; Day 85
Change from Screening in Aberrant Behavior Checklist (ABC) Subscale Scores
Change from Screening in Clinical Global Impression Severity (CGI-S) Scores
up to Day 106
Number of Participants with Severe Treatment-emergent Adverse Events
up to Day 85
Number of Participants with Clinically Significant 12-lead Electrocardiogram Findings
Number of Participants with Clinically Significant Physical Examination Procedure Findings
up to Day 92
Number of Participants with Clinically Significant Clinical Laboratory Parameter Values
Number of Participants with Clinically Significant Vital Sign Values
Number of Participants with a Positive Response to Questions Regarding Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Autism Spectrum Disorder

Side Effects for

GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set
21%Somnolence
16%Upper respiratory tract infection
16%Decreased appetite
10%Status epilepticus
10%Diarrhoea
9%Pyrexia
9%Irritability
7%Fatigue
6%Vomiting
6%Insomnia
4%Nasopharyngitis
4%Pneumonia
4%Lethargy
3%Headache
3%Convulsion
1%Sleep apnoea syndrome
1%Pancreatitis
1%Cholecystitis chronic
1%Pneumonia bacterial
1%Pneumonia respiratory syncytial viral
1%Transaminases increased
1%Aspartate aminotransferase increased
1%Sedation
1%Dehydration
1%Hypoventilation
1%Hypoxia
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02224560) in the GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set ARM group. Side effects include: Somnolence with 21%, Upper respiratory tract infection with 16%, Decreased appetite with 16%, Status epilepticus with 10%, Diarrhoea with 10%.

Trial Design

2 Treatment Groups

GWP42003-P 10 mg/kg/day
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

160 Total Participants · 2 Treatment Groups

Primary Treatment: GWP42003-P · Has Placebo Group · Phase 2

GWP42003-P 10 mg/kg/day
Drug
Experimental Group · 1 Intervention: GWP42003-P · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 29; day 85

Who is running the clinical trial?

GW Research LtdLead Sponsor
34 Previous Clinical Trials
3,067 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
1 Patients Enrolled for Autism Spectrum Disorder
Jazz PharmaceuticalsLead Sponsor
212 Previous Clinical Trials
29,598 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
101 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 12 kilograms (kg) in weight.
You are willing and able (in the investigator's opinion) to comply with all trial requirements.
You have a score of 15 or more on the ABC-I irritability subscale.
You must be able to swallow the IMP, provided as a liquid solution.
You are willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law.
You are willing and able to give informed assent and consent for participation in the trial.
You have a clinical global impression of your condition that is moderate to severe.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York50.0%
Arizona50.0%
How old are they?
< 18100.0%
What site did they apply to?
Clinical Trial Site50.0%
Richmond Behavioral Associates50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%