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 dystrophy; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12605000078651
• Lead Sponsor: The Children's Hospital at Westmead

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-05
• Last Update Posted: 13 January 2020

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).]