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NCT01838655 · ClinicalTrials.gov registry record · Phase 1
Nitisinone for Type 1B Oculocutaneous Albinism
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01838655 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT01838655, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: \- Oculocutaneous albinism, type 1B (OCA1B) is a genetic disease caused by problems in the gene that makes tyrosine. Tyrosine is an amino acid needed to produce pigment in the skin, hair, and eyes. People with OCA1B have pale skin, white hair, and light-colored eyes. Pigment in the back of the eye helps vision, so people with OCA-1B often have visual problems. Researchers want to see if a drug called nitisinone can help improve eye pigmentation and vision in people with OCA1B. Nitisinone is approved for treating a related genetic disease that causes problems with tyrosine, so it may help people with OCA1B. Objectives: \- To see if nitisinone can help improve eye pigmentation and vision in people with OCA1B. Eligibility: \- Individuals at least 18 years of age who have OCA1B. Design: * This study will last about 18 months. It requires eight outpatient visits, each about 3 months apart. Each visit will require 1 to 2 days of testing. * Participants will be screened with a physical exam, eye exam, and medical history. They will have additional vision and neurological tests. They will be tested to see how their brain and retinas respond to light. They will also take hair and blood samples, and answer questions about diet. * Participants will receive the study drug. They will take one pill a day for 1 year. They will keep track of the dose in a study diary. * At the outpatient visits, participants will have the following tests: * Medical history and physical exam * Neurological and eye exams * Retina function tests * Tests of the skin and brain's response to light * Blood and urine tests * Dietary consultation * Visual function questionnaire. * After the end of the study, participants will return to the care of their regular eye doctor.
Interventions
- DRUG Nitisinone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-04-16 |
| Est. Completion | 2017-02-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01838655
The ClinicalTrials.gov registry entry for NCT01838655 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nitisinone is the first listed.
NCT01838655 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01838655 about?
NCT01838655 is a clinical study titled "Nitisinone for Type 1B Oculocutaneous Albinism". Background: \- Oculocutaneous albinism, type 1B (OCA1B) is a genetic disease caused by problems in the gene that makes tyrosine. Tyrosine is an amino acid needed to produce pigment in the skin, hair, and eyes. People with OCA1B have pale skin, white hair, and light-colored eyes. Pigment in the back...
What is the current status of trial NCT01838655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2013-04-16. Estimated completion is 2017-02-07.
What interventions are being tested in trial NCT01838655?
The interventions under investigation include: Nitisinone (DRUG).
Who is sponsoring clinical trial NCT01838655?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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