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)

NCT05182697 | Recruiting DMC

• 1 other identifier: SCRC21013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)

Conditions

Autism Spectrum Disorder (ASD)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 weeks

Secondary Outcomes (8)

• Evaluate the safety of SCI-210 in children with ASD.

  24 weeks

• Evaluate the tolerability of SCI-210 in children with ASD.

  24 weeks

• Assess the efficacy of SCI-210 in reducing disruptive behaviors among children with ASD

  20 weeks

• Assess the efficacy of SCI-210 in reducing sleep problems among children with ASD

  20 weeks

• Assess the efficacy of SCI-210 in reducing ASD symptoms among children with ASD.

  20 weeks

Study Arms (2)

SCI-210

EXPERIMENTAL

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

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.

Drug: Oral CBD oil

Interventions

SCI-210 DRUG

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

SCI-210

Oral CBD oil DRUG

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

CBD oil

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• SciSparc: lead
• Negev Autism Center Soroka University Medical Center: collaborator

Study Sites (1)

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

Beersheba, 8457108, Israel

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Gal Meiri, MD, MHA

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Zuloff-Shani, PhD

CONTACT

972-3-7175777; adi@scisparc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 10, 2022
• Study Start: February 21, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)