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

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)

This study is testing a new treatment made from CBD oil and another compound to see if it can help children and young adults with autism feel better and manage their behavior.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 5 Years to 18 Years
• Sex: All
• Sponsor: Neurothera Labs Inc. (Industry-sponsored)
• Locations: 1 site (Beersheba)
• Trial ID: NCT05182697 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 5 to 18 diagnosed with ASD and exhibiting moderate or greater behavioral issues.

Not a fit: Patients currently receiving cannabis, antipsychotic drugs, or stimulants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve behavioral symptoms in children with autism.

How similar studies have performed: While this specific combination has not been tested in clinical trials before, anecdotal evidence suggests potential benefits in ASD treatment.

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.

Where this trial is running

Beersheba

• 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

Conditions Autism Spectrum Disorder