A randomized phase III study to evaluate the effects of Oxpentifyllene as an add on therapy for boys with duchenne muscular dystrophy in improving muscle strength and function.
Phase 3
Completed
- Conditions
- Duchenne muscular dystrophyMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12605000078651
- Lead Sponsor
- The Children's Hospital at Westmead
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Duchenne muscular dystrophy, ambulant, stable dose of steroids for 12 months.
Exclusion Criteria
No exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Muscle strength[Evaluated at the start of the trial (prior to the commencement of treatment drug or placebo), 1 month, 4 months, 8 months and 12 months after starting on the trial.]
- Secondary Outcome Measures
Name Time Method Assessment for changes in inflammation and muscle fibrosis.[At the start of the trial, and after the conclusion of the trial (12 months after starting Oxpentifylline or placebo).]
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does Oxpentifyllene target to improve muscle strength in Duchenne muscular dystrophy?
How does Oxpentifyllene compare to corticosteroids in improving muscle function for Duchenne patients?
Are there specific biomarkers that predict response to Oxpentifyllene in Duchenne muscular dystrophy?
What are the known adverse events associated with Oxpentifyllene add-on therapy in muscular dystrophy?
What other compounds or combination therapies are being explored alongside Oxpentifyllene for Duchenne muscular dystrophy?