Autistic DisorderPhase 2NCT05413187
A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder
A Phase 2 study testing Medical Grade Cannabis oil in people with Autistic Disorder, run by TO Pharmaceuticals at 1 site in Israel.
Trial summary
This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Medical Grade Cannabis oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to 1 Sep 2022
- Phase
- Phase 2
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Signed informed consent
- Children ages two to eight years old with a documented diagnosis of ASD.
- Children with a previous report of behavioral issues characterized by aggression, anxiety, restlessness, sleep disturbances and/or self-harm, all as a part of the ASD, as documented in previous clinical estimation and examination.
- Hebrew speaking and reading.
Who cannot join
- Children that are treated with cannabis, anti-psychotic drugs or stimulants.
- Children with a comorbidity of heart, liver, kidney or hematologic disease.
- Children that are treated with one of the following drugs: Astemizole, Cisapride, Pimozide or Terfenadine.
- Children that suffer from epilepsy
- Children which themselves or a first-degree family member suffer from psychosis and/or another mental illness.
- Children in any condition in which the investigator is of the opinion that participating in the study is not the best option for them.
- Children who underwent surgery during the 30 days prior to the trial.
- Children that are participating in another trial which includes any intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo Controlled, Randomized Trial to Assess the Efficacy and Safety of Medical Grade Cannabis (MGC) in Children Diagnosed With Autism Spectrum Disorder
This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.
Read the detailed description
Visit 1 - Screening and Enrollment The screening and enrollment procedures will take place at the Preschool Psychiatric Unit in Soroka University Medical Center (SUMC). Parents of children who meet all inclusion criteria and none of the exclusion criteria will be offered to participate in this trial. Interested parents will sign an informed consent form (ICF) and receive a copy. A medical cannabis license request will be sent to the Medical Cannabis Unit ("Yakar") for cannabis treatment for the child and upon approval the patient will be enrolled to the trial.
Medical history will be assessed, patients who do not have a general and neurologic exam during the past year previous to the initiation of the trial will be referred to their physician. Clinical and behavioral assessment will be performed by the investigator, vital signs and weight and height will be measured, and a urine sample will be taken. All concomitant medication taken by the patient will be documented.
The YAKAR's medical cannabis license application form and a confidentiality waiver form will be sent to the YAKAR. The physician will explain to the patient the medical license conditions and that the patient's participation in the trial can be terminated at any time.
Visit 2 - Randomization and Initiation of Phase 1 When the medical cannabis license arrives, a copy of the patient's license will be included into the trial source documents. Prior to randomization inclusion and exclusion criteria will be re-assessed to make sure the patient is eligible to participate in the trial.
A clinical and behavioral evaluation will be held by the investigator and will also include the following questionnaires:
- The Aberrant Behavior Checklist-Community (ABC-C)
- The Children's Sleep Habit Questionnaire (CSHQ)
- Sensory Profile II (SP-2) Questionnaire A urine sample will be taken for the presence of cannabis. The patient will participate in a 10-minute eye tracking test. A detailed guidance and instructions on the use of the IP at home will be given by a member of the trial team.The IP (drug or placebo based upon randomization) will be administered to the parents. The first dose administration will take place in the morning after the visit.
A compliance diary will be handed out to the parents and they will be instructed to fill out the daily administration of the IP.
Visit 3 (week 6 ± 5 days) Mid Phase 1 During this visit, a clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1) and the investigator. The patient compliance diary will be reviewed and returned to the parents for further documentation. Adverse events and concomitant medications will be reported and documented.
Visit 4 (week 12 ± 7 days) End of Phase 1 During this visit, parents will return the used IP. A clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1, CSHQ and SP-2) and the investigator, vital signs and weight will be measured.
The patient's compliance diary will be reviewed and returned to the parents for further documentation and adverse events and concomitant medications will be reported and documented.
The patient will participate in a 10-minute eye tracking test. Immediately after this visit, a four-week washout period will be initiated and no investigational product will be administered.
Visit 5 (week 16 ± 10) Crossover and Initiation of Phase 2 During this visit, the IP will be crossed over, and those who were first randomized to receive placebo will now receive the product and vice versa.
A clinical and behavioral evaluation will be held by the investigator and will also include the following questionnaires (ABC-C, CGI-1, CSHQ and SP-2), urine sample will be taken for the presence of cannabis and the patient will participate in a 10-minute eye tracking test. In addition, the patient compliance diary will be reviewed and returned to the parents for further documentation and adverse events and concomitant medications will be reported and documented.
A detailed guidance and instructions on the use of the IP at home will be given by a member of the trial team. The first dose administration will be the morning after the visit.
Visit 6 (week 22 ± 5) Mid-Phase 2 During this visit, a clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1) and the investigator. The patient compliance diary will be reviewed and returned to the parents for further documentation. Adverse events and concomitant medications will be reported and documented.
Visit 7 (week 28 ± 7) End of Phase 2 During this visit, parents will return the used IP. A clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1, CSHQ and SP-2) and the investigator. Vital signs and weight will be measured, the patient compliance diary will be returned and adverse events and concomitant medications will be reported and documented.
The patient will participate in a 10-minute eye tracking test. Visit 8 (week 32 ± 14) End of Trial During this visit, a clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1) and the investigator. Vital signs and weight and height will be measured and a urine sample will be taken for the presence of cannabis. Adverse events and concomitant medications will be reported and documented.
EEG Sub-study Parents will receive an explanation regarding the option to participate in an overnight EEG exams performed in the sleep laboratory at SUMC. This test is not mandatory for participation in the trial but will help researches assess the influence cannabis has on brain activity during sleep. Participating children and parents will be invited to three overnight EEG exams throughout the trial: right after enrollment and before initiating the trial (baseline), again right after the end of phase one (week 12-16), and a third and final exam right after the end of phase two (week 28-32).
- Conditions
- Autistic Disorder
- Being tested
- Medical Grade Cannabis oil, Placebos
- Keywords
- Cannabis, Autism
- Medical subject headings
- Autistic Disorder, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Grade Cannabis oilDrug
Also called Cannabis oil
MGC, 30% CBD and 1.5% Δ9-THC
PlacebosDrug
Olive oil and Chlorophyl
| Study group | Role | What they receive |
|---|---|---|
| Medical Grade Cannabis oil 30% CBD ,1.5% Δ9-THC | Active comparator | during phase 1; subjects will receive cannabis oil. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase. Receives: Drug: Medical Grade Cannabis oil |
| Olive oil and Chlorophyl | Placebo comparator | during phase 1; subjects will receive placebo. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in symptoms of Autism spectrum disorder
Superiority in reducing symptoms of Autism spectrum disorder as described and quantified via parent questionnaires and clinical assessment held by a specialized physician, in five main categories - sensory behavior, social relating, body and object use, language and communication skills, and social and adaptive skills. Clinical estimation will be held via the Aberrant Behavior Checklist-Community (ABC-C) questionnaire. Clinical estimation will be performed at the beginning and the end of each phase. Comparison will be held between clinical estimation results after treatment with MCG versus after treatment with placebo for both arms.
Measured: 32 weeks
Secondary outcomes (4)
change in score of The Clinical Global Impressions-Improvement (CGI-I)
Superiority in reducing symptoms of Autism spectrum disorder as described and quantified via parent questionnaire - The Clinical Global Impressions-Improvement (CGI-I). Clinical estimation will be performed at the beginning and the end of each phase. Comparison will be held between clinical estimation results after treatment with MCG versus after treatment with placebo for both arms.
Measured: 32 weeks
change in score of Sensory Profile II (SP-2)
assessed by the Sensory Profile II (SP-2) questionnaire. Parents will answer the questionnaire at the beginning and the end of each trial phase and a comparison will be held within each arm according to baseline and between both arms.
Measured: 32 weeks
Changes in eye movements
tracking as participants observe movies with social information. An eye tracking (ET) experiment will be performed at the beginning and end of each phase to examine changes in the way the children observe movies with social information (e.g. children playing). A comparison will be held within each arm according to baseline and between both arms.
Measured: 32 weeks
Changes in the sleep architecture (optional)
Parents will receive an explanation regarding the option to participate in an overnight EEG exams performed in the sleep laboratory at SUMC. This test is not mandatory for participation in the trial but will help researches assess the influence cannabis has on brain activity during sleep. Participating children and parents will be invited to three overnight EEG exams throughout the trial: right after enrollment and before initiating the trial (baseline), again right SCRC17039 Version 1.1, March 2018 Page 34 of 51 CONFIDENTIAL This material is the property of TO Pharma LLC. The information is confidential and is to be used only in connection with matters authorized by the sponsor and no part of it is to be without prior written permission from TO Pharma LLC.
after the end of phase one (week 12-16), and a third and final exam right after the end of phase two (week 28-32).
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: withdrawn due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Approximately forty children between the ages of two to eight years old with a documented diagnosis of Autism. The trial population will be randomized in a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TO Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lihi Bar-LEv, Study director, Clinical team manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413187
- Sponsor's protocol ID
- SCRC17039
- Status last verified
- Jun 2022
- First submitted
- 24 Apr 2019
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled, Randomized Trial to Assess the Efficacy and Safety of Medical Grade Cannabis (MGC) in Children Diagnosed With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05413187
- Acronym / sponsor ID
- SCRC17039
- Conditions
- Autistic Disorder
- Keywords
- Cannabis, Autism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TO PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.
Detailed description
Visit 1 - Screening and Enrollment The screening and enrollment procedures will take place at the Preschool Psychiatric Unit in Soroka University Medical Center (SUMC). Parents of children who meet all inclusion criteria and none of the exclusion criteria will be offered to participate in this trial. Interested parents will sign an informed consent form (ICF) and receive a copy. A medical cannabis license request will be sent to the Medical Cannabis Unit ("Yakar") for cannabis treatment for the child and upon approval the patient will be enrolled to the trial.
Medical history will be assessed, patients who do not have a general and neurologic exam during the past year previous to the initiation of the trial will be referred to their physician. Clinical and behavioral assessment will be performed by the investigator, vital signs and weight and height will be measured, and a urine sample will be taken. All concomitant medication taken by the patient will be documented.
The YAKAR's medical cannabis license application form and a confidentiality waiver form will be sent to the YAKAR. The physician will explain to the patient the medical license conditions and that the patient's participation in the trial can be terminated at any time.
Visit 2 - Randomization and Initiation of Phase 1 When the medical cannabis license arrives, a copy of the patient's license will be included into the trial source documents. Prior to randomization inclusion and exclusion criteria will be re-assessed to make sure the patient is eligible to participate in the trial.
A clinical and behavioral evaluation will be held by the investigator and will also include the following questionnaires:
- The Aberrant Behavior Checklist-Community (ABC-C)
- The Children's Sleep Habit Questionnaire (CSHQ)
- Sensory Profile II (SP-2) Questionnaire A urine sample will be taken for the presence of cannabis. The patient will participate in a 10-minute eye tracking test. A detailed guidance and instructions on the use of the IP at home will be given by a member of the trial team.The IP (drug or placebo based upon randomization) will be administered to the parents. The first dose administration will take place in the morning after the visit.
A compliance diary will be handed out to the parents and they will be instructed to fill out the daily administration of the IP.
Visit 3 (week 6 ± 5 days) Mid Phase 1 During this visit, a clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1) and the investigator. The patient compliance diary will be reviewed and returned to the parents for further documentation. Adverse events and concomitant medications will be reported and documented.
Visit 4 (week 12 ± 7 days) End of Phase 1 During this visit, parents will return the used IP. A clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1, CSHQ and SP-2) and the investigator, vital signs and weight will be measured.
The patient's compliance diary will be reviewed and returned to the parents for further documentation and adverse events and concomitant medications will be reported and documented.
The patient will participate in a 10-minute eye tracking test. Immediately after this visit, a four-week washout period will be initiated and no investigational product will be administered.
Visit 5 (week 16 ± 10) Crossover and Initiation of Phase 2 During this visit, the IP will be crossed over, and those who were first randomized to receive placebo will now receive the product and vice versa.
A clinical and behavioral evaluation will be held by the investigator and will also include the following questionnaires (ABC-C, CGI-1, CSHQ and SP-2), urine sample will be taken for the presence of cannabis and the patient will participate in a 10-minute eye tracking test. In addition, the patient compliance diary will be reviewed and returned to the parents for further documentation and adverse events and concomitant medications will be reported and documented.
A detailed guidance and instructions on the use of the IP at home will be given by a member of the trial team. The first dose administration will be the morning after the visit.
Visit 6 (week 22 ± 5) Mid-Phase 2 During this visit, a clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1) and the investigator. The patient compliance diary will be reviewed and returned to the parents for further documentation. Adverse events and concomitant medications will be reported and documented.
Visit 7 (week 28 ± 7) End of Phase 2 During this visit, parents will return the used IP. A clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1, CSHQ and SP-2) and the investigator. Vital signs and weight will be measured, the patient compliance diary will be returned and adverse events and concomitant medications will be reported and documented.
The patient will participate in a 10-minute eye tracking test. Visit 8 (week 32 ± 14) End of Trial During this visit, a clinical and behavioral evaluation will be held via questionnaires (ABC-C, CGI-1) and the investigator. Vital signs and weight and height will be measured and a urine sample will be taken for the presence of cannabis. Adverse events and concomitant medications will be reported and documented.
EEG Sub-study Parents will receive an explanation regarding the option to participate in an overnight EEG exams performed in the sleep laboratory at SUMC. This test is not mandatory for participation in the trial but will help researches assess the influence cannabis has on brain activity during sleep. Participating children and parents will be invited to three overnight EEG exams throughout the trial: right after enrollment and before initiating the trial (baseline), again right after the end of phase one (week 12-16), and a third and final exam right after the end of phase two (week 28-32).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Approximately forty children between the ages of two to eight years old with a documented diagnosis of Autism. The trial population will be randomized in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Medical Grade Cannabis oil 30% CBD ,1.5% Δ9-THC | Active comparator | Drug: Medical Grade Cannabis oilduring phase 1; subjects will receive cannabis oil. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase. |
| Olive oil and Chlorophyl | Placebo comparator | Drug: Placebosduring phase 1; subjects will receive placebo. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Signed informed consent
- Children ages two to eight years old with a documented diagnosis of ASD.
- Children with a previous report of behavioral issues characterized by aggression, anxiety, restlessness, sleep disturbances and/or self-harm, all as a part of the ASD, as documented in previous clinical estimation and examination.
- Hebrew speaking and reading.
Key exclusion criteria (8 listed)
- Children that are treated with cannabis, anti-psychotic drugs or stimulants.
- Children with a comorbidity of heart, liver, kidney or hematologic disease.
- Children that are treated with one of the following drugs: Astemizole, Cisapride, Pimozide or Terfenadine.
- Children that suffer from epilepsy
- Children which themselves or a first-degree family member suffer from psychosis and/or another mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Grade Cannabis oilAlso: Cannabis oilMGC, 30% CBD and 1.5% Δ9-THC | Drug | Medical Grade Cannabis oil 30% CBD ,1.5% Δ9-THC |
| PlacebosOlive oil and Chlorophyl | Drug | Olive oil and Chlorophyl |
Primary outcome
change in symptoms of Autism spectrum disorder
Time frame: 32 weeks
Superiority in reducing symptoms of Autism spectrum disorder as described and quantified via parent questionnaires and clinical assessment held by a specialized physician, in five main categories - sensory behavior, social relating, body and object use, language and communication skills, and social and adaptive skills. Clinical estimation will be held via the Aberrant Behavior Checklist-Community (ABC-C) questionnaire. Clinical estimation will be performed at the beginning and the end of each phase. Comparison will be held between clinical estimation results after treatment with MCG versus after treatment with placebo for both arms.
4 secondary outcomes
change in score of The Clinical Global Impressions-Improvement (CGI-I)
Time frame: 32 weeks
change in score of Sensory Profile II (SP-2)
Time frame: 32 weeks
Changes in eye movements
Time frame: 32 weeks
Changes in the sleep architecture (optional)
Time frame: 32 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lihi Bar-LEv study director
Clinical team manager
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medical Grade Cannabis oil in people with Autistic Disorder, run by TO Pharmaceuticals 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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 Jun 2022. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
change in symptoms of Autism spectrum disorder (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2022.