Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT07199218
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 4 to 12 years (after the 4th birthday and before the 13th).
2. Diagnosis of autism spectrum disorder (ASD) according to DSM-5, confirmed by Childhood Autism Rating Scale-Second Edition (CARS-2).
3. Moderate or greater ASD-associated symptoms, defined as a rating of ≥4 ("moderate" or higher) on the Overall Function Clinical Global Impression-Severity (CGI-S).
4. Aberrant Behavior Checklist-Irritability subscale (ABC-I) score ≥18.
5. Social Responsiveness Scale-Second Edition (SRS-2) total T score ≥66.
Exclusion Criteria:
1. Body weight \<12.5 kg or ≥57.5 kg.
2. Current or past diagnosis of heart failure, drug addiction, schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder (PTSD), or major depressive disorder (MDD), or diagnosis of schizophrenia in a first-degree relative.
3. Seizure or change in antiepileptic medications within 4 months prior to randomization.
4. Clinically significant abnormalities on physical examination or laboratory testing, including impairment in cardiac, hepatic, or renal function.
5. Change in pharmacological or behavioral treatment, or change in home or school environment (other than school holidays), within 4 weeks prior to randomization or planned during the study.
6. Cannabinoid treatment within 4 weeks prior to randomization.
7. Predicted poor compliance with study procedures (e.g., blood tests).
8. Concurrent use of opiates or alcohol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
13 Years
Study:
NCT07199218
Study Brief:
Protocol Section:
NCT07199218