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)

Launched by SCISPARC · Dec 21, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called SCI-210 for children and young adults with Autism Spectrum Disorder (ASD). The main goal is to see if SCI-210 is safe and effective for managing the symptoms of ASD. The study is currently recruiting participants aged 5 to 18 who have a confirmed diagnosis of ASD and are experiencing moderate to severe behavioral challenges. A parent or legal guardian must be involved to give consent and help with assessments throughout the trial.

To participate, children must not be taking certain medications like cannabis or antipsychotics, and they should not have serious health issues like heart or liver problems. Participants will be monitored closely during the study, and their development and behavior will be assessed regularly. This trial is important because it aims to find new ways to support children with ASD, potentially leading to better treatment options in the future.

Gender

ALL

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.