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NCT01617070 · ClinicalTrials.gov registry record · Phase 4
Effects of Kuvan on Melatonin Secretion
A Phase 4 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT01617070: Completed Phase 4 study, sponsored by University of Southern California.
NCT01617070 is a Phase 4 study that has completed, run by University of Southern California. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01617070, a Phase 4 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)
Interventions
- DRUG Kuvan
- DIETARY_SUPPLEMENT Large Neutral Amino Acid Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01617070 record still lists
NCT01617070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Kuvan is the first listed.
NCT01617070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01617070 about?
NCT01617070 is a clinical study titled "Effects of Kuvan on Melatonin Secretion". 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 ex...
What is the current status of trial NCT01617070?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2012-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01617070?
The interventions under investigation include: Kuvan (DRUG), Large Neutral Amino Acid Therapy (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01617070?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01617070's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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