Nitric Oxide Supplementation on Neurocognitive Functions in Patients With ASLD (NCT03064048) | Clinical Trial Compass
CompletedNot Applicable
Nitric Oxide Supplementation on Neurocognitive Functions in Patients With ASLD
United States16 participantsStarted 2017-09-15
Plain-language 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.
Who can participate
Age range
6 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 6 and \<50 years
. Diagnosis of ASLD confirmed by biochemical OR enzymatic OR genetic testing
. Has a history of compliance with diet and treatment
. Negative pregnancy test and ability to use birth control method for the entire duration of the study (if the subject is of child-bearing potential)
. Males who enroll in the study (and their partners) should argee to use an acceptable form of birth control for the entire duration of the study
Exclusion criteria
. Clinical or laboratory abnormality of Grade 3 or greater according to the CTCAE (or for conditions not covered by the CTCAE, a severe or life-threatening toxicity) at enrollment which, in the view of the investigator compromises safety. (Elevated plasma levels of aspartate and alanine aminotransferases, or low serum potassium will not be considered as exclusion criteria as these are phenotypic manifestations of ASLD.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delis-Kaplan Executive Function System - Tower subtest
Timeframe: 24 weeks
2
Stanford-Binet - 4th Edition: Bead Memory and Sentence Memory subtests
Timeframe: 24 weeks
3
Grip Strength
Timeframe: 24 weeks
4
Grooved Pegboard
Timeframe: 24 weeks
5
Wechsler Intelligence Scale for Children OR Wechsler Adult Intelligence Scale - 4th Edition (in subjects > 16 years of age)
Timeframe: 24 weeks
6
Tower of London Test
Timeframe: 24 weeks
7
Conners Continuous Performance Test - 3rd Edition Conners Continuous Performance Test - 3rd Edition