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| Sponsor: | University of Utah |
|---|---|
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00346853 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Dystrophy, Corneal |
Drug: 4-Methylpyrazole Other: saline |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Clinical Interventions Against Stargardt Macular Dystrophy: Phase 1 Pilot Study of 4-MP as an Inhibitor of Dark Adaptation |
| Enrollment: | 10 |
| Study Start Date: | November 2005 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: 4-Methylpyrazole
15 mg/kg dose
|
|
2: Placebo Comparator
saline
|
Other: saline |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Utah | |
| Moran Eye Center, University of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| Principal Investigator: | Paul S Bernstein, M.D., Ph.D. | University of Utah |
More Information
| Responsible Party: | Department of Ophthalmology ( Dr. Randall Olson, Chair ) |
| Study ID Numbers: | 4-MP Dark Adaptation Inhib. |
| Study First Received: | June 28, 2006 |
| Last Updated: | July 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00346853 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Dark adaptation inhibition Stargardt macular dystrophy 4-Methylpyrazole (4-MP) Antizol Fomepizole |
|
Corneal Diseases Genetic Diseases, Inborn Corneal Dystrophies, Hereditary Eye Diseases Physiological Effects of Drugs |
Fomepizole Eye Diseases, Hereditary Protective Agents Pharmacologic Actions Antidotes |
