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NCT03064048 · ClinicalTrials.gov registry record · NA
Nitric Oxide Supplementation on Neurocognitive Functions in Patients With ASLD
A NA study of Urea Cycle Disorder and Argininosuccinic Aciduria, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03064048: Completed NA study of Urea Cycle Disorder and Argininosuccinic Aciduria, sponsored by Baylor College of Medicine.
NCT03064048 is a NA study of Urea Cycle Disorder and Argininosuccinic Aciduria that has completed, run by Baylor College of Medicine. The registered enrollment target is 16 participants, below the 46-participant average among 4 other Urea Cycle Disorder trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03064048, a NA study of Urea Cycle Disorder and Argininosuccinic Aciduria, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study involving a dietary supplement. Patients with argininosuccinate lyase deficiency (ASLD) will be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 24 weeks, and then crossed-over to receive the other treatment for 24 weeks. The investigators will assess the effects of the supplement in domains of general cognition, memory, executive functioning, and fine motor functioning in individuals with ASLD.
Primary Outcome
Change in the scores from baseline to 24 weeks with drug vs placebo
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Neo-ASA
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2023-01-31 |
| Phase | NA |
What the finished NCT03064048 record still lists
NCT03064048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 46-participant average among 4 other Urea Cycle Disorder trials with a reported enrollment target (65% lower).
The record links to 4 conditions, with Urea Cycle Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03064048 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03064048 about?
NCT03064048 is a clinical study titled "Nitric Oxide Supplementation on Neurocognitive Functions in Patients With ASLD". This is a study involving a dietary supplement. Patients with argininosuccinate lyase deficiency (ASLD) will be randomly assigned to receive either a nitric oxide dietary supplement or placebo for 24 weeks, and then crossed-over to receive the other treatment for 24 weeks. The investigators will ass...
What is the current status of trial NCT03064048?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2017-09-15. Estimated completion is 2023-01-31.
What conditions does trial NCT03064048 study?
This clinical trial studies the following conditions: Urea Cycle Disorder, Argininosuccinic Aciduria, Urea Cycle Disorders, Inborn, Argininosuccinate Lyase Deficiency.
What interventions are being tested in trial NCT03064048?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Neo-ASA (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03064048?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03064048 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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