Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy - Tabular View

Tracking Information

First Received Date ^ICMJE

June 28, 2006

Last Updated Date

July 9, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer.

Change History

Complete list of historical versions of study NCT00346853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy

Official Title ^ICMJE

Clinical Interventions Against Stargardt Macular Dystrophy: Phase 1 Pilot Study of 4-MP as an Inhibitor of Dark Adaptation

Brief 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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Macular Dystrophy, Corneal

Intervention ^ICMJE

Drug: 4-Methylpyrazole
Other: saline

Study Arms / Comparison Groups

Placebo Comparator: saline

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All nonpregnant, nonlactating adults with normal vision in both eyes

Exclusion Criteria:

Previous ocular pathologies

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00346853

Responsible Party

Dr. Randall Olson, Chair, Department of Ophthalmology

Study ID Numbers ^ICMJE

4-MP Dark Adaptation Inhib.

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Paul S Bernstein, M.D., Ph.D.

University of Utah

Information Provided By

University of Utah

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP