A randomised phase III study to evaluate the effectiveness prednisolone therapy for late stage Duchenne muscular dystrophy in maintaining lung functio

Phase 3

• Conditions: Musculoskeletal - Other muscular and skeletal disorders; Duchenne muscular dystrophy

• Registration Number: ACTRN12605000076673
• 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: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Duchenne muscular dystrophy, non-ambulant.

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ung function[Lung function and echocardiograms are done prior to starting on prednisolone; repeated at 6 and 12 months after starting on prednisolone and the echo will be repeated 12 months after starting on the prednisolone.]

Secondary Outcome Measures

Name	Time	Method
pper limb strength[Measured prior to commencement of study medication and then every 3 months after starting medication.];Scoliosis[Assessed clinically and by lateral X-ray prior to commencing study medication, and at the conclusion of the trial.];Bone densitometry[Measured prior to and at the conclusion of the trial.];Behaviour and quality of life[Measured prior to commencement of study meds, and then 3 monthly (behaviour) and 6 monthly (QoL).]