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:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT06293950
Eligibility Criteria:
Inclusion Criteria:
* 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD
Exclusion Criteria:
* Age \> 14 years.
* Patient weighing \< 10 kg.
* History of severe Allergy
* History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.
* Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.
* Evidence or history of severe, moderate, or uncontrolled systemic disease.
* Inability to follow the prescribed dosing and follow-up schedule.
* Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period.
* Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study.
* History of premature birth \<35 weeks' gestation.
* Prior history of stroke in utero or other in utero insult.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
14 Years
Study:
NCT06293950
Study Brief:
Protocol Section:
NCT06293950