Using SCI-210 to treat children and young adults with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of SCI-210, a novel compound combining CBD oil and CannAmide, in treating Autism Spectrum Disorder (ASD) in children and young adults. The approach leverages the 'entourage effect' to enhance the therapeutic potential of CBD by using PEA to improve anandamide responses. Participants aged 5 to 18 with moderate behavioral problems will be monitored for treatment effects and safety. The study aims to provide insights into the effectiveness of this combination therapy for alleviating ASD symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Gal Meiri, MD, MHA — Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
• Study coordinator: Adi Zuloff-Shani, PhD
• Email: adi@scisparc.com
• Phone: 972-3-7175777

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.