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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 is a Phase 4 study that has completed, run by University of Southern California. The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01617070
The ClinicalTrials.gov registry entry for NCT01617070 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Kuvan is the first listed.
NCT01617070 reports 0 study locations.
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.
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