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Effects of Kuvan on Melatonin Secretion

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Trial Status Completed

Trial Identifier

NCT01617070

Condition

Phenylketonuria, Phenylketonuria (PKU)

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial 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.

Eligibility Criteria

Birth Sex

All

Age

From 18 Years

Healthy Volunteers

No

Drug/Treatment:

Kuvan, Large Neutral Amino Acid Therapy

Phase:

Phase 4

Study Type:

Interventional

Number of Participants:

10

Study Started:

2012-05

Study Updated:

2016-11-18

Trial Locations

  • Keck School of Medicine, Clinical Trials Unit at Keck Medical Center of USC

    Los Angeles, California, United States

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

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