What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that modulate the endocannabinoid system, such as Cannabidiol (CBD), have shown mixed results in clinical trials. Side effects of CBD can include gastrointestinal issues, such as nausea and diarrhea, as well as potential interactions with other medications. Omega-3 fatty acids, another treatment studied for ASD, are generally well-tolerated but can cause gastrointestinal distress, including nausea and diarrhea. Both treatments should be used with caution in patients with specific sensitivities or underlying conditions.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Autism Spectrum Disorder (ASD) that focus on the modulation of the endocannabinoid system, such as cannabidiol (CBD). The provided context does not mention any FDA approvals for such treatments. Generally, treatments for ASD focus on behavioral therapies and medications to manage symptoms like irritability, but these do not typically involve the endocannabinoid system.

What other types of research exist?

Promising novel alternatives to Cannabidiol (CBD) for Autism Spectrum Disorder (ASD) patients include: 1) Behavioral and educational interventions targeting sensory challenges, 2) Omega-3 fatty acid supplementation, although evidence is inconsistent, 3) Dietary modifications such as gluten-free casein-free diets, though these are not recommended without specific sensitivities, and 4) Emerging pharmacological treatments like NAC (N-acetylcysteine) and gabapentin, which have shown some efficacy in related conditions. It is important to consult with a healthcare provider to evaluate the suitability and safety of these treatments for individual patients.

← Back to Search

Cannabinoid

Cannabidiol for Autism

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 younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called GWP42003-P to see if it can help reduce symptoms in children with Autism Spectrum Disorder (ASD). The goal is to find out if this medication can make managing ASD easier for these children.

Who is the study for?

This trial is for children and adolescents with Autism Spectrum Disorder (ASD) who are moderately ill, weigh at least 12 kg, have an IQ of 70 or higher, and stable ASD-related treatments. They must be able to swallow liquid medication and not have other dominating conditions like ADHD or a history of substance abuse. Participants cannot be taking certain medications like clobazam or more than two anti-epileptic drugs.

What is being tested?

The study tests the effectiveness of Cannabidiol Oral Solution (GWP42003-P; CBD-OS) versus a placebo in reducing symptoms of ASD in children. It's designed to see if this treatment can help manage the condition better compared to not receiving the active drug.

What are the potential side effects?

While specific side effects aren't listed here, potential side effects may include reactions related to cannabidiol such as changes in appetite, mood alterations, drowsiness, digestive issues, and possible allergic reactions due to any excipients present in the solution.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Headache

Convulsion

Lethargy

Status epilepticus

Insomnia

Irritability

Pneumonia

Lymphopenia

Constipation

Pneumatosis intestinalis

Adenovirus infection

Pneumonia mycoplasmal

Respiratory syncytial virus infection

Delayed recovery from anaesthesia

Aspartate aminotransferase increased

Alanine aminotransferase increased

Gamma-glutamyltransferase increased

Pleural effusion

Device malfunction

Hypotension

100%

80%

60%

40%

20%

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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GWP42003-P 10 mg/kg/dayExperimental Treatment1 Intervention

Participants will be stratified based on their age (6 to 11 years old, 12 to 17 years old), use of antipsychotics (on versus off), and region (North America versus Rest of the World) and will be randomized to receive 5 milligrams per kilogram per day (mg/kg/day) GWP42003-P for 1 week and then 10 mg/kg/day GWP42003-P for 11 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GWP42003-P

2016

Completed Phase 3

~1740

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) include behavioral therapies, medications, and emerging treatments like Cannabidiol (CBD). CBD works by modulating the endocannabinoid system, which plays a role in regulating mood, social behavior, and neurological development. This modulation can help reduce symptoms such as anxiety, aggression, and repetitive behaviors in ASD patients. Understanding these mechanisms is crucial as it provides insight into how CBD and similar treatments can improve the quality of life for individuals with ASD by targeting specific neurological pathways involved in the disorder.