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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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19 October 2017 |
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Main ID: |
NCT01617070 |
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Date of registration:
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08/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Kuvan on Melatonin Secretion
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Scientific title:
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Pilot Study to Evaluate Melatonin Secretion as a Marker of Decreased Serotonin in Individuals With PKU: Evaluation of the CNS Effects of Tetrahydrobiopterin |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01617070 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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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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Shoji Yano, M.D., Ph.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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USC Keck School of Medicine, Dept. of Pediatrics, Genetics Division |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult English-speaking patients who have confirmed PKU, and have tolerated Kuvan
therapy at 20 mg/kg/day in the past, and are currently on the LNAA supplements will be
considered as candidates for the study.
- Subjects must be able to stop LNAA therapy for 4 weeks.
- This will be determined by the subjects themselves, based on their past personal
experiences.
Exclusion Criteria:
- Individuals who have never taken Kuvan, who have never been on LNAA therapy, who are
under the age of 18, or who do not speak English will be excluded.
- Subjects who cannot stop LNAA therapy for 4 weeks will be excluded.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Phenylketonuria (PKU)
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Intervention(s)
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Dietary Supplement: Large Neutral Amino Acid Therapy
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Drug: Kuvan
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Primary Outcome(s)
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Urine 6-sulfatoxymelatonin at the End of 4 Weeks
[Time Frame: measured every 4 weeks up to 16 weeks]
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Urine Dopamine at the End of 4 Weeks
[Time Frame: measured every 4 weeks up to 16 weeks]
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Serum Melatonin at the End of 4 Weeks
[Time Frame: measured every 4 weeks up to 16 weeks]
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Secondary ID(s)
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USC Kuvan Melatonin
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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