NCT05182697Recruiting
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)
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)
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 29 Nov 2021
- Start date
- 21 Feb 2024
- Primary completion date
- May 2026
- Lead sponsor
- Neurothera Labs Inc.
- Diseases
- Autism
- NCT number
- NCT05182697
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 21 Feb 2024 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Children who are already receiving cannabis, antipsychotic drugs, or stimulants.
- Exposure to any investigational agent in the 30 days prior to trial onset.
- Subjects who have had changes in non-exclusionary psychotropic medications within 4 weeks of initiation of trial.
Other illness
- 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
- A current psychiatric diagnosis of bipolar disorder, major depressive disorder (MDD), psychosis, schizophrenia, or post-traumatic stress disorder (PTSD)
- Allergic to cannabinoids or PEA tablet components.
- 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.
Lab values
- History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel.
Who the study is looking for
- 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
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel Coordinator of this site? Confirm its status | Beersheba | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.