Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033813
Status:
COMPLETED
Last Update Posted:
2014-03-10
First Post:
2002-04-10
Brief Title:
KUL0401 An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy
Sponsor:
Cooperative International Neuromuscular Research Group
Organization:
Cooperative International Neuromuscular Research Group
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
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:
This study will help to determine the safety and efficacy of the mast cell stabilizer Oxatomide as a treatment for Duchenne muscular dystrophy DMD Boys with DMD who are enrolled in this study will should not have taken steroids to treat DMD for at least twelve months and should not have taken any nutritional supplements for at least three months Subjects will complete a two screening visits within a one-week period and if enrolled will then have their strength tested monthly for three months before beginning therapy with Oxatomide Once Oxatomide therapy is started participants will have their strength tested monthly for six months Following the six month treatment period participants will be given the option to remain on Oxatomide until the study is completed
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