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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCI-210, Oral CBD oil.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder (ASD). Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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 responses in non-vascular tissues. This effect is called "entourage effect". The "entourage effect" can be achieved by enhancing the action of endogenous anandamide through an increase in the affinity for receptors and/or a decrease in enzymatic degradation of anandamide (primarily by fatty acid amide hydrolase, FAAH). Thus, the combination of CBD oil with PEA is believed to be more effective than CBD oil alone, while AEs are not increased by the addition of the natural substance PEA.
SCI-210 has not been tested in clinical trials before, but anecdotal evidence of combined use of CBD and CannAmide in ASD patients has been accumulated in recent months. The evidence suggests the beneficial effects of the combination in alleviating ASD symptoms with no reported adverse events associated with the treatment.
Interventions
- Drug SCI-210
Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily - Drug Oral CBD oil
CBD- active CBD oil with twice daily CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.
Primary outcome measures
- Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) [Time frame: 24 weeks]
- Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) [Time frame: 24 weeks]
- Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) [Time frame: 24 weeks]
Secondary outcome measures (8)
- Evaluate the safety of SCI-210 in children with ASD. [Time frame: 24 weeks]
- Evaluate the tolerability of SCI-210 in children with ASD. [Time frame: 24 weeks]
- Assess the efficacy of SCI-210 in reducing disruptive behaviors among children with ASD [Time frame: 20 weeks]
- Assess the efficacy of SCI-210 in reducing sleep problems among children with ASD [Time frame: 20 weeks]
- Assess the efficacy of SCI-210 in reducing ASD symptoms among children with ASD. [Time frame: 20 weeks]
- Assess the efficacy of SCI-210 in improving adaptive behaviors among children with ASD [Time frame: 20 weeks]
- Assess the efficacy of SCI-210 in improving language abilities among children with ASD [Time frame: 20 weeks]
- Assess the effects of SCI-210 on eye tracking measures when viewing social movies. [Time frame: 20 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-S — Beersheba
Identifiers
NCT: NCT05182697 · SCRC21013