Status:
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)
Lead Sponsor:
SciSparc
Collaborating Sponsors:
Negev Autism Center Soroka University Medical Center
Conditions:
Autism Spectrum Disorder (ASD)
Eligibility:
All Genders
5-18 years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05182697
Start Date
February 21 2024
End Date
June 1 2026
Last Update
May 16 2025
Active Locations (1)
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1
Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
Beersheba, Israel, 8457108