Actively Recruiting
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)
Led by Neurothera Labs Inc. · Updated on 2025-05-16
60
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
N
Neurothera Labs Inc.
Lead Sponsor
N
Negev Autism Center Soroka University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 outlined in the Medical Cannabis unit circular on Licenses for cannabis use, Procedure number 106, version 5 dated Jan 2021
You will not qualify if you...
- 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
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
Beersheba, Israel, 8457108
Actively Recruiting
Research Team
A
Adi Zuloff-Shani, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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