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Autism Spectrum DisorderPhase 3NCT05212493

The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder

A Phase 3 study testing Cannabis oil in people with Autism Spectrum Disorder, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 25 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Cannabis oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteIsrael
Study dates
14 Nov 2019to 31 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • Epilepsy with clinical symptoms
  • Current or previous treatment with cannabis
  • Genetic disorder that can cause ASD symptoms
  • Metabolic disorder
  • immunologic disorder
  • liver cancer
Show all 11Show fewer
  • Participants who, in the researcher's opinion, will not cooperate in the various research procedures
  • Women which are pregnant or breastfeeding.
  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

About this study

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.

Read the detailed description

Participants will be screened by the PI, a specialist neurologist. For those passing screening, license for Cannabis will be obtained at MOH.

Participants will pass tests such as ADOS (communication skills) and Wechsler (IQ), parents will fill questionnaires.

Treatment will start in a titration mode till improvement in some parameters is seen or till treatment failure decision is made.

Participants will be called for a check-up by mid-time (after 3 months) and their parents will fill questionnaires.

Participants will be called for a last check-up after 6 months from treatment beginning and pass again ADOS and Wechsler tests. Parents will fill questionnaires.

Secondary purposes of the trial:

To detect side-effects To assess treatment failure To assess treatment effect on sleep, motor restlessness and behavior. To examine treatment effect on hormonal profile

Being tested
Cannabis oil
Keywords
Autism, Cannabis, co-morbid symptoms, ASD, Cannabidiol
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis oilDrug

    Cannabis oil 20:1 CBD:THC ratio

Study groups in NCT05212493
Study groupRoleWhat they receive
Seach CBD:THC 20:1 cannabis oilActive comparatorcannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Seach LTD and oil manufactured by Nextar Pharma LTD.
Receives: Drug: Cannabis oil
Candoc CBD:THC 20:1 cannabis oilActive comparatorcannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Candoc LTD and oil manufactured by Panaxia LTD.
Receives: Drug: Cannabis oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cannabinoids levels change

    To compare CBD, THC their and metabolites blood levels before and after intervention

    Measured: 3 months

  2. Changes in attention span

    To characterize the effect of medical cannabis treatment on the attention span using Conners teacher questionnaires. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

    Measured: 6 months

  3. Changes in cognitive level

    To examine the effect of cannabis treatment on cognitive level using part of Wechsler test. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

    Measured: 6 months

  4. Comparison of efficacy between two different cannabis oil products

    To compare efficacy of medical cannabis products with the same CBD: THC ratio in terms of communication skills using ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

    Measured: 6 months

  5. Changes in adaptive behavior

    To examine the effect of cannabis treatment on adaptive behavior as per ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

    Measured: 6 months

  6. Changes in violent behavior

    To examine the effect of cannabis treatment on violent behavior as per specific trial-designed questionnaire. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

    Measured: 6 months

Secondary outcomes (6)

  1. Side effects

    To identify side effects as per parents report in a specific trial-designed questionnaire. Significant change is defined as a change of 10% in new side effects as examined by questionnaire score between baseline and 6 months.

    Measured: 6 months

  2. Therapeutic failure

    To identify therapeutic failure reasons as per Professional expert opinion. Significant reason is defined as reason that will effect at least 20% of therapeutic failure cases.

    Measured: 6 months

  3. Changes in sleep problems

    To examine whether high concentration CBD cannabis oil is effective in improving sleep as per Sleep questionnaire. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

    Measured: 6 months

  4. Changes in eating problems

    To examine whether high concentration CBD cannabis oil is effective in improving eating as per eating questionnaire. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

    Measured: 6 months

  5. Changes in hormonal profile

    To compare hormonal profile measured as per by Hospital Lab SOP before and during treatment. measured hormones are: TSH, FT4, 17OH-testosterone, LH, prolactine. Significant change is defined as a clinically significant diversion from lab defined normal ranges, according to age and sex, between baseline and 3 months.

    Measured: 3 months

  6. Changes in biochemical parameters

    To compare liver enzymes measured as per by Hospital Lab SOP before and during treatment. Measured enzymes are: ALT, AST, GGT, Bilirubin. Significant change is defined as a clinicaly significant diversion (more than twice the Upper Limit of Noraml for each enzyme) from lab defined normal ranges, between baseline and 3 months.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2022
  2. Study start14 Nov 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05212493
Sponsor's protocol ID
0281-17-ASF
Other IDs
20175083
Status last verified
Jul 2024
First submitted
12 Dec 2021
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: the study protocol to be sahared upon request

Publications

  • Iseger TA, Bossong MG. A systematic review of the antipsychotic properties of cannabidiol in humans. Schizophr Res. 2015 Mar;162(1-3):153-61. doi: 10.1016/j.schres.2015.01.033. Epub 2015 Feb 7.

    PubMed 25667194

  • Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015 Jun 23-30;313(24):2456-73. doi: 10.1001/jama.2015.6358.

    PubMed 26103030

  • Barchel D, Stolar O, De-Haan T, Ziv-Baran T, Saban N, Fuchs DO, Koren G, Berkovitch M. Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-morbidities. Front Pharmacol. 2019 Jan 9;9:1521. doi: 10.3389/fphar.2018.01521. eCollection 2018.

    PubMed 30687090

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cannabis oil in people with Autism Spectrum Disorder, run by Assaf-Harofeh Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cannabinoids levels change (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05212493, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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