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Effects of Kuvan on Melatonin Secretion

NCT01617070 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-11-18

Study results available
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Summary

This study examines the effect of tetrahydrobiopterin (Kuvan) and Large Neutral Amino Acid (LNAA) therapy on melatonin and dopamine levels in individuals with Phenylketonuria (PKU). The investigators hypothesize that Kuvan therapy will improve melatonin secretion and urine dopamine levels to some extent. However significantly greater responses in melatonin and dopamine secretions may be observed with combined treatment with Kuvan and supplementation of LNAA.

Conditions

  • Phenylketonuria (PKU)

Interventions

DRUG

Kuvan

Dosed at 20 mg/kg; PO; Phase 3, Phase 4

DIETARY_SUPPLEMENT

Large Neutral Amino Acid Therapy

Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food

Sponsors & Collaborators

Principal Investigators

  • Shoji Yano, M.D., Ph.D. · USC Keck School of Medicine, Dept. of Pediatrics, Genetics Division

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01617070 on ClinicalTrials.gov