CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Kuvan +1 moredrug
Likely dose
Kuvan 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01617070
NCT01617070Phase 4Completed
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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

University of Southern California·interventional·Posted Jun 12, 2012·Updated Nov 18, 2016

In Brief

A Phase 4 clinical trial evaluating Kuvan and Large Neutral Amino Acid Therapy for Phenylketonuria (PKU). Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria (PKU)
CountriesUnited States
CollaboratorsBioMarin Pharmaceutical

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 12, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.1 years ago

Interventions

Kuvandrug

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

Large Neutral Amino Acid Therapydietary

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