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 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT00132366
Eligibility Criteria:
* INCLUSION CRITERIA
Patients
* Persistent 4-hydroxybutyric aciduria (gamma-hydroxybutyric aciduria)
* Documented succinic semialdehyde dehydrogenase enzyme deficiency
* English-speaking (or the ability to understand English as a second language)
* Patients must have clinically documented SSADH deficiency.
* Patients may be male or female.
* Female patients of child bearing potential will have a pregnancy test prior to the study to ensure that pregnant patients will not participate in the study.
* During the study, women of child bearing potential must use a reliable method of birth control.
Patients will be aged 5-24
Parents will be aged 18-55
Adult Healthy Volunteers will be aged 18-55
Child Healthy Volunteers will be aged 10-17
EXCLUSION CRITERIA
* Major debilitating mental or physical illness that would interfere with participation.
* Pregnancy or lactation
* Use of alcohol or recreational drugs during the study
* Patients with progressive neurologic disorders
* Patients with a history of significant medical disorders
* Patients requiring treatment of drugs known to affect the GABAergic system, including vigabatrin.
* Patients with cancer.
* Patients who had seizure activity 24 hours prior to the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
55 Years
Study:
NCT00132366
Study Brief:
Protocol Section:
NCT00132366