Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004646
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
OBJECTIVES I Characterize the effect of prednisone on muscle protein metabolism in patients with Duchenne muscular dystrophy
II Determine whether prednisone changes levels of insulin-like growth factor 1 growth hormone and insulin
III Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin
IV Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy
II Determine whether prednisone changes levels of insulin-like growth factor 1 growth hormone and insulin
III Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin
IV Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are randomly assigned to prednisone or placebo Therapy is administered daily for 12 weeks prednisone is then tapered
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| URMC-2251 | None | None | None |