Clinical Trial

Systemic Biomarkers of Brain Injury From Hyperammonemia

Recruiting
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Record status
This record was last updated February 7, 2024 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
Ammonia is a waste product of protein and amino acid catabolism and is also a potent neurotoxin. High blood ammonia levels on the brain can manifest as cytotoxic brain edema and vascular compromise leading to intellectual and developmental disabilities. The following aims are proposed: Aim 1 of this study will be to determine the chronology of biomarkers of brain injury in response to a hyperammonemic (HA) brain insult in patients with an inherited hyperammonemic disorder. Aim 2 will be to determine if S100B, NSE, and UCHL1 are altered in patients with two other inborn errors of metabolism, Maple Syrup Urine Disease (MSUD) and Glutaric Acidemia (GA1).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-10-20; most recent amendment 2024-02-06.
Trial Details
NCT Number NCT04602325
Lead Sponsor Children's National Research Institute
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions Urea Cycle Disorder, Organic Acidemia, Maple Syrup Urine Disease, Glutaric Acidemia I, Fatty Acid Oxidation Disorder, Hypoxic-Ischemic Encephalopathy
Enrollment 24 participants
Start Date 2020-07-09
Primary Completion 2026-07 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2024-02-07