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)
| NCT ID | NCT05182697 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neurothera Labs Inc. |
| Condition | Autism Spectrum Disorder (ASD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-02-21 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)
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.
Contact & Investigator
Gal Meiri, MD, MHA
PRINCIPAL INVESTIGATOR
Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel
Frequently Asked Questions
Who can join the NCT05182697 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Autism Spectrum Disorder (ASD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05182697 currently recruiting?
Yes, NCT05182697 is actively recruiting participants. Contact the research team at adi@scisparc.com for enrollment information.
Where is the NCT05182697 trial being conducted?
This trial is being conducted at Beersheba, Israel.
Who is sponsoring the NCT05182697 clinical trial?
NCT05182697 is sponsored by Neurothera Labs Inc.. The principal investigator is Gal Meiri, MD, MHA at Clinical Research Center and Negev Autism Center Soroka University Medical Center, Be'er-Sheva, Israel. The trial plans to enroll 60 participants.