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 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT02508259
Eligibility Criteria:
Inclusion Criteria:
* Autism diagnostic observation schedule (ADOS) score of ≥ 7
* Diagnosis of autism spectrum disorder by Diagnostic and Statistical Manual, 5th edition (DSM-V)
* Stable treatment and diet regimen for ≥ 2 months
* Resident of San Diego region
Exclusion Criteria:
* Any prescription medications
* Hospitalization within the previous 2 months
* Active medical problem such as seizures, heart, liver, kidney, or adrenal disease
* Planning to start a new drug, diet, or behavioral intervention during the study
* Weight under the 5th percentile for age
* Unable to tolerate venipuncture, urine collection, or an indwelling intravenous catheter for 3-4 hours
* Plasma creatinine ≥ 1.4 mg/dl
* Liver function alanine amino transferase (ALT) or aspartate amino transferase (AST) ≥ 1.5-fold above the upper limit of normal
* Known intolerance to suramin or other antipurinergic drugs
* Unable to perform or cooperate with study requirements
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT02508259
Study Brief:
Protocol Section:
NCT02508259