Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243789
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2005-10-21
Brief Title:
Study of Daily Pentoxifylline as a Rescue Treatment in Duchenne Muscular Dystrophy
Sponsor:
Cooperative International Neuromuscular Research Group
Organization:
Cooperative International Neuromuscular Research Group
Study Overview
Official Title:
A Double-Blinded Randomized Placebo Controlled Study of Daily Pentoxifylline as a Rescue Treatment in DMD
Status:
COMPLETED
Status Verified Date:
2011-10
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 see if male children with Duchenne muscular dystrophy DMD have changes in strength when given the drug Pentoxifylline as a rescue treatment A total of 64 subjects are expected to participate through all other centers of the Cooperative International Neuromuscular Research Group CINRG worldwide
The primary purpose of this study is to see whether the addition of pentoxifylline to a steroid regimen is effective in treating deteriorating muscle strength by comparing the muscle strength of PTX treated subjects and placebo treated subjects
The primary purpose of this study is to see whether the addition of pentoxifylline to a steroid regimen is effective in treating deteriorating muscle strength by comparing the muscle strength of PTX treated subjects and placebo treated subjects
Detailed Description:
DMD is the most common and devastating type of muscular dystrophy incidence 1 in 3500 live born males worldwide DMD is characterized by a complete loss of dystrophin leading to progressive muscle weakness and wasting
No cure is currently available despite our present understanding of the disorder and the discovery and characterization of the causative gene and its protein product dystrophin in 1987 Corticosteroids prednisone deflazacort may delay disease progression and until now it is the only treatment that proved to be beneficial for patients with DMD Other alternative supplements like creatine and glutamine also delay diseased progression
No cure is currently available despite our present understanding of the disorder and the discovery and characterization of the causative gene and its protein product dystrophin in 1987 Corticosteroids prednisone deflazacort may delay disease progression and until now it is the only treatment that proved to be beneficial for patients with DMD Other alternative supplements like creatine and glutamine also delay diseased progression
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