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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02477904
Eligibility Criteria:
Inclusion Criteria:
* Ages 2-21 years.
* Primary diagnosis of autism spectrum disorder.
* Parent/legal guardian and child able to read or understand English, and able/willing to provide informed consent/assent.
* Females of childbearing potential must have a negative pregnancy test result and agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug - childbearing potential is defined a girls who are \> Tanner stage 2 and urine pregnancy tests are acceptable.
Exclusion Criteria:
* Known cardiac disorder including arrhythmias or hypertension.
* BMI \< 3rd%ile.
* Carnitine deficiency (primary).
* Carnitine palmitoyltransferase (CPT) I or II deficiency.
* Carnitine translocase deficiency.
* Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3-hydroxyacyl-CoA deficiency.
* Pyruvate carboxylase deficiency.
* Porphyria.
* Inability to maintain adequate nutrition.
* Patient or caregiver non-compliance.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT02477904
Study Brief:
Protocol Section:
NCT02477904