Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00346853 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy
A Phase 1 study of Macular Dystrophy, Corneal, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT00346853 is a Phase 1 study of Macular Dystrophy, Corneal that has completed, run by University of Utah. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00346853, a Phase 1 study of Macular Dystrophy, Corneal, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if 4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these processes, individuals with Stargardt disease may have better chances of saving their remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by shutting down the body's ability to process alcohols. This medication has an excellent safety profile and has been reported to have no short-term or long-term side effects, as long as patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment to save Stargardt patients' vision, and may also have similar effects in other macular degenerative diseases.
Conditions Studied
Interventions
- OTHER saline
- DRUG 4-Methylpyrazole
Study Locations (1)
Utah
- Moran Eye Center, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-11 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00346853
The ClinicalTrials.gov registry entry for NCT00346853 describes a study currently listed as completed, categorized as Phase 1. 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 Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Macular Dystrophy, Corneal appearing as the primary indexed condition, and to 2 interventions - of which saline is the first listed.
NCT00346853 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT00346853 about?
NCT00346853 is a clinical study titled "Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy". The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if 4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these processes, individuals with Stargardt d...
What is the current status of trial NCT00346853?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2005-11. Estimated completion is 2006-09.
What conditions does trial NCT00346853 study?
This clinical trial studies the following conditions: Macular Dystrophy, Corneal.
What interventions are being tested in trial NCT00346853?
The interventions under investigation include: saline (OTHER), 4-Methylpyrazole (DRUG).
Who is sponsoring clinical trial NCT00346853?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00346853 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.