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Clinical Trials in Israel / NCT05182697
Recruiting Not applicable

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)

NCT05182697 · tracked via the Priya Life Science Israel tracker
Sponsor
Neurothera Labs Inc
Phase
Not applicable
Started
2024-02-21
Last updated
2025-05-16

Condition(s) studied

Autism Spectrum Disorder (ASD)

Investigational drug(s) / intervention(s)

SCI-210Oral CBD oil →

SCI-210: Oral CBD oil plus pills of CannAmide (palmitoylethanolamide (PEA) 400 mg twice daily

Oral CBD oil: CBD- active CBD oil with twice daily CannAmide Placebo pills matched in appearance and taste to CannAmide active pill.

Study summary

To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)

Eligibility

Sex
ALL
Min age
5 Years
Max age
18 Years
Healthy volunteers
No
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 outcome measure(s)

  • Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) — 24 weeks
    Evaluation of the safety of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. Adverse effects will be assessed using an adverse effects checklist (AEC) containing 19 items from the Liverpool Adverse Events Profile (LAEP) in addition to 15 items that have been used previously to assess side effects of CBD. These will be compared between the groups. Dropout rates from study will also be compared between these groups.
  • Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) — 24 weeks
    Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. The primary outcome measures of the study will be the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in CGI-I scores during the different periods of the study between the two treatment and control groups.
  • Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) — 24 weeks
    Evaluation of the efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD) throughout the 24 week treatment period. The primary outcome measures of the study will be the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire performed by a clinician. These will be completed at the beginning (Time 0), middle (4 weeks) and end (8 weeks) of each stage. Efficacy of treatment will be evaluated by comparing the change in ABC-C scores during the different periods of the study between the two treatment and control groups.

Trial sites (1)

FacilityCityRegionStatus
Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel Beersheba Israel Recruiting

More Neurothera Labs Inc. trials in Israel

SCI-110 in the Treatment of Tourette Syndrome Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05182697 on ClinicalTrials.gov ↗ ← All trials in Israel