NCT05212493CompletedPhase 3
The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 31 Jul 2024
Brief summary (registry, in English)
Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis extract use for ASD is promising but still limited. The aim of this study is to investigate if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities of autism, including sleep and eating problems, anxiety and violence. The main objectives of the study are: 1) to characterize the effect of treatment with cannabis oil on comorbid symptoms of ASD; 2) to compare safety and efficacy of different cannabis products with identical CBD:THC ratio; 3) to investigate the effect of treatment on cognitive and adaptive behavior; and 4) to measure THC and CBD and metabolites levels in the blood of the patients. In this study, patients diagnosed with ASD will be treated with cannabidiol-rich cannabis oil (CBD:THC ratio of 20:1). The researchers will collect parental reports on ASD comorbid symptoms before and bi-weekly during 6 months of the study period. Blood tests will be performed before and after three months of treatment. Blood tests include blood count, blood chemistry, hormones profile, phyto- and endo- cannabinoids and metabolites. Cognitive evaluation will be done before and after six months of treatment. Electroencephalogram (EEG) to exclude epilepsy will be performed before and after six months of treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 12 Dec 2021
- Start date
- 14 Nov 2019
- Primary completion date
- 31 Dec 2021
- Lead sponsor
- Assaf-Harofeh Medical Center
- Diseases
- Autism
- NCT number
- NCT05212493
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 128
- From 14 Nov 2019 to the primary completion date, 31 Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous treatment with cannabis
Other illness
- Epilepsy with clinical symptoms
- Genetic disorder that can cause ASD symptoms
- Metabolic disorder
- immunologic disorder
- liver cancer
- Psychosis or schizophrenia or past or present schizoaffective disorder, in first-degree relatives
- History of substance abuse or abuse (including cannabis use disorder or alcohol addiction) in first-degree relatives
- Hypersensitivity to coconut oil / palm oil
Other
- Participants who, in the researcher's opinion, will not cooperate in the various research procedures
- Women which are pregnant or breastfeeding.
Who the study is looking for
- diagnosed with ASD by DSM
- IQ below 70. The investigator can include patients with IQ above 70 if they have significant ASD or comorbid symptoms.
- With significant behavior problems in for at least 6 months before recruitment
Age in the registry: 5 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assaf Harofeh Medical Center Coordinator of this site? Confirm its status | Tsrifin | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.