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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 March 2023 |
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Main ID: |
NCT03064048 |
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Date of registration:
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10/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Nitric Oxide Supplementation on Neurocognitive Functions in Patients With ASLD
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Scientific title:
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Effect of Nitric Oxide (NO) Supplementation on Neurocognitive Measures in Argininosuccinate Lyase Deficiency (ASLD) |
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Date of first enrolment:
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September 15, 2017 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03064048 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Brendan Lee, M.D., PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Name:
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Sandesh C Nagamani, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age > 6 and <50 years
2. Diagnosis of ASLD confirmed by biochemical OR enzymatic OR genetic testing
3. Has a history of compliance with diet and treatment
4. 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)
5. 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:
1. 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.)
2. Known hypersensitivity to Neo-ASA or nitrite
3. Individuals currently being administered other investigational agents
Age minimum:
6 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Argininosuccinate Lyase Deficiency
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Urea Cycle Disorders, Inborn
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Argininosuccinic Aciduria
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Urea Cycle Disorder
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Neo-ASA
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Primary Outcome(s)
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Conners Continuous Performance Test - 3rd Edition Conners Continuous Performance Test - 3rd Edition
[Time Frame: 24 weeks]
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Stanford-Binet - 4th Edition: Bead Memory and Sentence Memory subtests
[Time Frame: 24 weeks]
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Tower of London Test
[Time Frame: 24 weeks]
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Grooved Pegboard
[Time Frame: 24 weeks]
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Grip Strength
[Time Frame: 24 weeks]
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Delis-Kaplan Executive Function System - Tower subtest
[Time Frame: 24 weeks]
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Wechsler Intelligence Scale for Children OR Wechsler Adult Intelligence Scale - 4th Edition (in subjects > 16 years of age)
[Time Frame: 24 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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