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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT00472732
Eligibility Criteria:
Inclusion Criteria for Participants with OTCD:
* Diagnosis of OTCD or heterozygote state of OTCD by metabolic or molecular means. Female participants must be clinically stable and heterozygous for OTCD. Male participants must be hemizygous for late onset OTCD.
Inclusion Criteria for Healthy Controls:
* No known medical or metabolic disorder
Inclusion Criteria for All Participants:
* IQ of at least 80
* Willing to travel to study site
* English-speaking
* Age between 18 and 60 years
Exclusion Criteria for All Participants:
* Currently being treated for an acute illness
* History of neuropsychiatric drug use
* Unable to undergo MRI scanning without being sedated
* Unable to participate in neurocognitive and/or motor testing
* Metal device in body that might interfere with MRI scanning
* Pregnancy or breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00472732
Study Brief:
Protocol Section:
NCT00472732