- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00346853
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy
August 3, 2020 updated by: University of Utah
Clinical Interventions Against Stargardt Macular Dystrophy: Phase 1 Pilot Study of 4-MP as an Inhibitor of Dark Adaptation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84132
- Moran Eye Center, University of Utah
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All nonpregnant, nonlactating adults with normal vision in both eyes
Exclusion Criteria:
- Previous ocular pathologies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
15 mg/kg dose
|
Placebo Comparator: 2
saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dark adaptation inhibition measured 30 minutes after drug infusion using Goldman-Weeker adaptometer.
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul S Bernstein, M.D., Ph.D., University of Utah
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
May 1, 2006
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
June 28, 2006
First Submitted That Met QC Criteria
June 28, 2006
First Posted (Estimate)
June 30, 2006
Study Record Updates
Last Update Posted (Actual)
August 5, 2020
Last Update Submitted That Met QC Criteria
August 3, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Genetic Diseases, Inborn
- Eye Diseases, Hereditary
- Corneal Diseases
- Macular Degeneration
- Corneal Dystrophies, Hereditary
- Stargardt Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protective Agents
- Antidotes
- Fomepizole
Other Study ID Numbers
- 4-MP Dark Adaptation Inhib.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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