Clinical trial NCT05182697: 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Lead sponsor: SciSparc
Sponsor class: INDUSTRY
Collaborators: name: Negev Autism Center Soroka University Medical Center
First posted: 2022-01-10
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
timeFrame: 24 weeks
measure: Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
timeFrame: 24 weeks
measure: Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
timeFrame: 24 weeks
Secondary outcomes:
measure: Evaluate the safety of SCI-210 in children with ASD.
timeFrame: 24 weeks
measure: Evaluate the tolerability of SCI-210 in children with ASD.
timeFrame: 24 weeks
measure: Assess the efficacy of SCI-210 in reducing disruptive behaviors among children with ASD
timeFrame: 20 weeks
measure: Assess the efficacy of SCI-210 in reducing sleep problems among children with ASD
timeFrame: 20 weeks
measure: Assess the efficacy of SCI-210 in reducing ASD symptoms among children with ASD.
timeFrame: 20 weeks
measure: Assess the efficacy of SCI-210 in improving adaptive behaviors among children with ASD
timeFrame: 20 weeks
measure: Assess the efficacy of SCI-210 in improving language abilities among children with ASD
timeFrame: 20 weeks
measure: Assess the effects of SCI-210 on eye tracking measures when viewing social movies.
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Be'er-Sheva
country: Israel
facility: Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
Study officials:
affiliation: Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
name: Gal Meiri, MD, MHA
role: PRINCIPAL_INVESTIGATOR
References: