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)

NCT ID: NCT05182697

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Autism Spectrum Disorder (ASD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SCI-210

Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily

Group Type: EXPERIMENTAL

SCI-210

Intervention Type: DRUG

Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily

CBD oil

CBD- active CBD oil with twice daily and CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.

Group Type: ACTIVE_COMPARATOR

Oral CBD oil

Intervention Type: DRUG

CBD- active CBD oil with twice daily CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.

Interventions

SCI-210

Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily

Intervention Type: DRUG

Oral CBD oil

CBD- active CBD oil with twice daily CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males or females aged between 5 and 18 years of age (inclusive)

2. Diagnosis of ASD confirmed by the ADOS-2 and DSM-5 criteria

3. Moderate or greater behavioral problems as measured by a rating of moderate or higher (≥4) on the Clinical Global Impression-Severity (CGI-S)

4. 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

5. 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

Exclusion Criteria

1. Children who are already receiving cannabis, antipsychotic drugs, or stimulants.

2. Children with heart, liver, renal or hematological disorders.

3. History of active seizure disorder or epilepsy; patients who are seizure free for more than 3 years can take part in the study

4. Exposure to any investigational agent in the 30 days prior to trial onset.

5. A current psychiatric diagnosis of bipolar disorder, major depressive disorder (MDD), psychosis, schizophrenia, or post-traumatic stress disorder (PTSD)

6. Subjects who have had changes in non-exclusionary psychotropic medications within 4 weeks of initiation of trial.

7. Allergic to cannabinoids or PEA tablet components.

8. History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel.

9. 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Negev Autism Center Soroka University Medical Center

UNKNOWN

Sponsor Role: collaborator

SciSparc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gal Meiri, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel

Locations

Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel

Beersheba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Adi Zuloff-Shani, PhD

Role: CONTACT

adi@scisparc.com

972-3-7175777

Facility Contacts

Gal Meiri, MD. MHA

Role: primary

GalMe@clalit.org.il

972 8 6244306

Other Identifiers

SCRC21013

Identifier Type: -

Identifier Source: org_study_id