At a glance
ClinicalIndex Comparison RecordN/ACompleted· 46 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 5
- ✓Diagnosis of OTCD (ornithine transcarbamylase deficiency) confirmed by metabolic or molecular testing; females must be clinically stable heterozygotes, males must be hemizygous for late-onset OTCD
- ✓IQ of at least 80
- ✓Age 18-60 years
- ✓Willing to travel to study site and English-speaking
Key exclusion· 6
- ✕Currently being treated for an acute illness
- ✕History of neuropsychiatric drug use
- ✕Unable to undergo MRI scanning without sedation
- ✕Metal device in body that might interfere with MRI scanning
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessing Neural Mechanisms of Injury in Inborn Errors of Urea Metabolism Using Structural MRI, Functional MRI, and Magnetic Resonance Spectroscopy
In Brief
An observational study for Brain Diseases, Metabolic, Inborn and 2 related conditions. Completed, enrolled 46 participants across 2 sites.
Detailed Summary
Urea cycle disorders (UCDs) are a group of rare inherited metabolism disorders. The purpose of this study is to evaluate how UCD-related neurologic injuries affect adults with one of the most common types of UCD.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Diseases, Metabolic, Inborn, Urea Cycle Disorder, Ornithine Transcarbamylase Deficiency
CountriesUnited States
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMay 2007
Primary CompletionJul 2009
Study CompletionJul 2010
TodayJul 2026
First PostedMay 14, 2007
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.1 years ago