Viewing Study NCT00451074



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Study NCT ID: NCT00451074
Status: COMPLETED
Last Update Posted: 2012-03-23
First Post: 2007-03-21

Brief Title: Six Month Study of Gentamicin in Duchenne Muscular Dystrophy With Stop Codons
Sponsor: Nationwide Childrens Hospital
Organization: Nationwide Childrens Hospital

Study Overview

Official Title: A Six Month Randomized Clinical Trial of Gentamicin in Duchenne Muscular Dystrophy Subjects With Stop Codon Mutations
Status: COMPLETED
Status Verified Date: 2012-03
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 determine the safety of giving intravenous IV gentamicin to boys with Duchenne muscular dystrophy who have stop codon mutations
Detailed Description: The primary purpose of this second cohort is to see if the IV Medication gentamicin is safe to give twice a week for six months to boys with Duchenne muscular dystrophy DMD Secondarily we want to know if gentamicin can help strengthen the muscles of boys with DMD who have a particular type of genetic mutation known as a stop codon The gentamicin is thought to allow for read-through of this type of mutation which would allow for the production of dystrophin a protein which is lacking in boys with DMD

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
Secondary IDs
Secondary ID Type Domain Link
7R01NS043186 NIH None httpsreporternihgovquickSearch7R01NS043186