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NCT01425528 · ClinicalTrials.gov registry record · Phase 1
Study of Kuvan Treatment in Adults With GTPCH Deficiency
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01425528 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 12 participants.
The verdict
NCT01425528, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH) deficiency and to asses the potential impact of oral Kuvan on mood and function in individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression, fatigue, trouble concentrating, or memory loss. This will be a phase one study. The investigators will monitor patients over a period of three to six months while on the medication. Medication levels will be monitored by measuring the BH4 levels in cerebral spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up lumbar punctures for this purpose. The investigators will also monitor emotional function and motor function.
Interventions
- DRUG Sapropterin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01425528
The ClinicalTrials.gov registry entry for NCT01425528 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sapropterin is the first listed.
NCT01425528 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01425528 about?
NCT01425528 is a clinical study titled "Study of Kuvan Treatment in Adults With GTPCH Deficiency". The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH) deficiency and to asses the potential impact of oral Kuvan on mood and function in individuals with GTPCH deficiency...
What is the current status of trial NCT01425528?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2011-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01425528?
The interventions under investigation include: Sapropterin (DRUG).
Who is sponsoring clinical trial NCT01425528?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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