Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346853
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2006-06-28
Brief Title:
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Clinical Interventions Against Stargardt Macular Dystrophy Phase 1 Pilot Study of 4-MP as an Inhibitor of Dark Adaptation
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None