Effects of Kuvan on Melatonin Secretion

Completed · Phase 4

Conditions studied: Phenylketonuria (PKU)

In brief

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.

Key facts

Study ID

NCT01617070

Run by

University of Southern California

People needed

10

Starts

2012-05-01

Expected to finish

2014-12-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Keck School of Medicine, Clinical Trials Unit at Keck Medical Center of USC — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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