Autism Spectrum Disorder (ASD)NCT05182697
SCI-210 in the Treatment of Children and Young Adults With AutismEvaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD)
A study testing SCI-210 and Oral CBD oil in people with Autism Spectrum Disorder (ASD), run by Neurothera Labs Inc. at 1 site in Israel.
Trial summary
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- SCI-210 and Oral CBD oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Feb 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females aged between 5 and 18 years of age (inclusive)
- Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria
- Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)
- Presence of a parent/legal guardian who is able to consent for their participation and completes assessments regarding the child's development and behavior throughout the study
- Patients eligible for cannabis treatment as regulated by the Israeli Ministry of Health, as out lined in the Medical Cannabis unit circular on Licenses for cannabis use, Procedure number 106, version 5 dated Jan 2021
Who cannot join
- Children who are already receiving cannabis, antipsychotic drugs, or stimulants.
- Children with heart, liver, renal or hematological disorders.
- History of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study
- Exposure to any investigational agent in the 30 days prior to trial onset.
- A current psychiatric diagnosis of bipolar disorder, major depressive disorder (MDD), psychosis, schizophrenia, or post-traumatic stress disorder (PTSD)
- Subjects who have had changes in non-exclusionary psychotropic medications within 4 weeks of initiation of trial.
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- Allergic to cannabinoids or PEA tablet components.
- History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel.
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
Beersheba, 8457108
Gal Meiri, MD. MHA, 972 8 6244306, GalMe@clalit.org.il
About this study
Official title: A Randomized, Double-Blind, Sparing-effect Placebo Controlled, With Cross-over Study to Evaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD)
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Read the detailed description
The innovative compound SCI-210 consists of CBD oil combined with CannAmide (PEA formulation) using the "entourage effect" to enhance efficacy of CBD. It is believed that PEA potentiates anandamide responses in non-vascular tissues. This effect is called "entourage effect". The "entourage effect" can be achieved by enhancing the action of endogenous anandamide through an increase in the affinity for receptors and/or a decrease in enzymatic degradation of anandamide (primarily by fatty acid amide hydrolase, FAAH). Thus, the combination of CBD oil with PEA is believed to be more effective than CBD oil alone, while AEs are not increased by the addition of the natural substance PEA.
SCI-210 has not been tested in clinical trials before, but anecdotal evidence of combined use of CBD and CannAmide in ASD patients has been accumulated in recent months. The evidence suggests the beneficial effects of the combination in alleviating ASD symptoms with no reported adverse events associated with the treatment.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- SCI-210, Oral CBD oil
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCI-210Drug
Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily
Oral CBD oilDrug
CBD- active CBD oil with twice daily CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.
| Study group | Role | What they receive |
|---|---|---|
| SCI-210 | Experimental | Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily Receives: Drug: SCI-210 |
| CBD oil | Active comparator | CBD- active CBD oil with twice daily and CannAmide Placebo pills matched in appearance and taste to CannAmide active pill. Receives: Drug: Oral CBD oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period.
Adverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
Measured: 24 weeks
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period.
The primary outcome measures of the study will be the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in CGI-I scores during the different periods of the study between the two treatment and control groups.
Measured: 24 weeks
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period.
The primary outcome measures of the study will be the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in ABC-C scores during the different periods of the study between the two treatment and control groups.
Measured: 24 weeks
Secondary outcomes (8)
Evaluate the safety of SCI-210 in children with ASD.
Evaluate the safety of SCI-210 in children with ASD throughout the 24 week treatment periodAdverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
Measured: 24 weeks
Evaluate the tolerability of SCI-210 in children with ASD.
Evaluate the tolerability of SCI-210 in children with ASD throughout the 24 week treatment period Adverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
Measured: 24 weeks
Assess the efficacy of SCI-210 in reducing disruptive behaviors among children with ASD
Parents will fill out the following questionnaire at the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage:
The Social Responsiveness Scale (SRS) will be used to estimate changes in the social abilities of the child.
A total composite score between 60 and 65 is associated with mild to moderate deficits in social interaction. Scores between 66 and 75 are considered to display a moderate deficit in social interaction, and a score greater than 76 is considered severe and strongly associated with the clinical diagnosis of ASD
Measured: 20 weeks
Assess the efficacy of SCI-210 in reducing sleep problems among children with ASD
Parents will fill out the following questionnaire at the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage:
The Children's Sleep Habit Questionnaire (CSHQ) will be used to estimate changes in the sleep quality of the child.
A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99. A Total Sleep Disturbances score of over 41 indicates a pediatric sleep disorde.
Measured: 20 weeks
Assess the efficacy of SCI-210 in reducing ASD symptoms among children with ASD.
Children will participate in the following assessment at the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage:
The Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) will be used to estimate changes in core ASD symptoms.
The comparison score ranges from 1-10, where 1 indicates minimal-to-no evidence of autism-related symptoms and 10 indicates a high level of impairment.
Measured: 20 weeks
Assess the efficacy of SCI-210 in improving adaptive behaviors among children with ASD
Parents will fill out the following questionnaire at the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage:
The Adaptive Behavior Assessment System 3rd edition (ABAS-3) will be used to estimate changes in the adaptive behaviors of the child.
The ratings given for each skill area are converted into a score from 1 to 19, with 1 being the lowest and 19 being the highest, and scores of 8 to 12 being in the Average range
Measured: 20 weeks
Assess the efficacy of SCI-210 in improving language abilities among children with ASD
Children will participate in the following assessment at the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage:
The Preschool Language Scale will be used to estimate changes in language abilities.
A standard score of 100 on this scale represents the performance of the typical student of a given age. Standard scores between 85 and 115 correspond to one standard deviation below and above the mean, respectively; scores within this range are considered to be within normal limits.
Measured: 20 weeks
Assess the effects of SCI-210 on eye tracking measures when viewing social movies.
Eye tracking assessment will be performedat the beginning (Time 0) of the trial and at the end of the first (8 weeks) and second (20 weeks) stage Eye tracking while watching movies will be performed to estimate changes in the way the children observe movies with social information (e.g., children playing). This will quantify changes in the social preferences of the child.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start21 Feb 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurothera Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Negev Autism Center Soroka University Medical Center
- Responsible party
- Sponsor
- Investigators
- Gal Meiri, MD, MHA, Principal investigator, Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182697
- Sponsor's protocol ID
- SCRC21013
- Status last verified
- May 2025
- First submitted
- 29 Nov 2021
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sparing-effect Placebo Controlled, With Cross-over Study to Evaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT05182697
- Acronym / sponsor ID
- SCRC21013
- Conditions
- Autism Spectrum Disorder (ASD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Neurothera Labs Inc.Industry (pharma, biotech, devices)
- Collaborators
- Negev Autism Center Soroka University Medical Center
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Jan 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.
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Detailed description
The innovative compound SCI-210 consists of CBD oil combined with CannAmide (PEA formulation) using the "entourage effect" to enhance efficacy of CBD. It is believed that PEA potentiates anandamide responses in non-vascular tissues. This effect is called "entourage effect". The "entourage effect" can be achieved by enhancing the action of endogenous anandamide through an increase in the affinity for receptors and/or a decrease in enzymatic degradation of anandamide (primarily by fatty acid amide hydrolase, FAAH). Thus, the combination of CBD oil with PEA is believed to be more effective than CBD oil alone, while AEs are not increased by the addition of the natural substance PEA.
SCI-210 has not been tested in clinical trials before, but anecdotal evidence of combined use of CBD and CannAmide in ASD patients has been accumulated in recent months. The evidence suggests the beneficial effects of the combination in alleviating ASD symptoms with no reported adverse events associated with the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI-210 | Experimental | Drug: SCI-210Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily |
| CBD oil | Active comparator | Drug: Oral CBD oilCBD- active CBD oil with twice daily and CannAmide Placebo pills matched in appearance and taste to CannAmide active pill. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Males or females aged between 5 and 18 years of age (inclusive)
- Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria
- Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)
- Presence of a parent/legal guardian who is able to consent for their participation and completes assessments regarding the child's development and behavior throughout the study
- Patients eligible for cannabis treatment as regulated by the Israeli Ministry of Health, as out lined in the Medical Cannabis unit circular on Licenses for cannabis use, Procedure number 106, version 5 dated Jan 2021
Key exclusion criteria (9 listed)
- Children who are already receiving cannabis, antipsychotic drugs, or stimulants.
- Children with heart, liver, renal or hematological disorders.
- History of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study
- Exposure to any investigational agent in the 30 days prior to trial onset.
- A current psychiatric diagnosis of bipolar disorder, major depressive disorder (MDD), psychosis, schizophrenia, or post-traumatic stress disorder (PTSD)
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 |
|---|---|---|
| SCI-210Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily | Drug | SCI-210 |
| Oral CBD oilCBD- active CBD oil with twice daily CannAmide Placebo pills matched in appearance and taste to CannAmide active pill. | Drug | CBD oil |
Primary outcome
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Time frame: 24 weeks
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. Adverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Time frame: 24 weeks
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. The primary outcome measures of the study will be the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in CGI-I scores during the different periods of the study between the two treatment and control groups.
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
Time frame: 24 weeks
Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. The primary outcome measures of the study will be the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in ABC-C scores during the different periods of the study between the two treatment and control groups.
8 secondary outcomes
Evaluate the safety of SCI-210 in children with ASD.
Time frame: 24 weeks
Evaluate the tolerability of SCI-210 in children with ASD.
Time frame: 24 weeks
Assess the efficacy of SCI-210 in reducing disruptive behaviors among children with ASD
Time frame: 20 weeks
Assess the efficacy of SCI-210 in reducing sleep problems among children with ASD
Time frame: 20 weeks
Assess the efficacy of SCI-210 in reducing ASD symptoms among children with ASD.
Time frame: 20 weeks
Assess the efficacy of SCI-210 in improving adaptive behaviors among children with ASD
Time frame: 20 weeks
Assess the efficacy of SCI-210 in improving language abilities among children with ASD
Time frame: 20 weeks
Assess the effects of SCI-210 on eye tracking measures when viewing social movies.
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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.
Gal Meiri, MD, MHA principal investigator
Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCI-210 and Oral CBD oil in people with Autism Spectrum Disorder (ASD), run by Neurothera Labs Inc. 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 May 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adi Zuloff-Shani, PhD (972-3-7175777, adi@scisparc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 16 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.