Status:
COMPLETED
Study of Daily Pentoxifylline as a Rescue Treatment in Duchenne Muscular Dystrophy
Lead Sponsor:
Cooperative International Neuromuscular Research Group
Conditions:
Muscular Dystrophy, Duchenne
Eligibility:
MALE
7+ years
Phase:
PHASE1
PHASE2
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 ar...
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 ...
Eligibility Criteria
Inclusion
- Male
- Age 7 years to 100 years
- Ability to ambulate for 10 meters. Assistive devices are allowed.
- Diagnosis of DMD confirmed by at least one the following:
- On stable dose of prednisone, prednisolone or deflazacort for at least 12 months prior to screening.
- Participants who are on stable dose of any combination of the following compounds (creatine, glutamine, coenzyme Q10, vitamin E, C or D, JUVEN, arginine, calcium) must have taken these medications for at least 2 months prior to screening. Subjects are not required to take these medications to participate in the study.
- All other herbs, supplements or green tea (other than those noted above) have been discontinued 3 months prior to screening.
- Ability to provide reproducible QMT bicep score with no more than 15% variation between scores during screening.
- Normal blood clotting ability evidenced by a platelet function assessment (PFA).
Exclusion
- Currently enrolled in another treatment clinical trial.
- History of significant concomitant illness or significant impairment of renal or hepatic function.
- History of impairment of blood clotting ability (as evidenced by increased PT/PTT or PFA over the upper limit of normal (ULN)).
- Recent cerebral or retinal hemorrhage.
- History of bleeding diathesis or gastric ulcer.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00243789
Start Date
September 1 2005
End Date
January 1 2008
Last Update
October 27 2011
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Washington University, St. Louis
St Louis, Missouri, United States, 63110
4
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213