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A randomized phase III study to evaluate the effectiveness of two different dosing regimens (high dose vs daily) of Prednisone for boys with Duchenne muscular dystrophy in improving muscle strength and function and minimising side effects.

A randomized phase III study to evaluate the effectiveness of two different dosing regimens (high dose vs daily) of Prednisone for boys with Duchenne muscular dystrophy in improving muscle strength and function and minimising side effects.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000075684
Enrollment
140
Registered
2005-08-05
Start date
2005-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To see which regimen of Prednisone - either a low daily dose or a high dose given on the two days of the weekend - gives the best positive effects (improvement in muscle strength) while minimising adverse effects (such as weight gain and behavioural changes)

Interventions

Comparison of daily low dose (0.75mg/kg/day) Prednisone to high dose Prednisone over 2 days (10mg/kg/week).

Sponsors

The Children's Hospital at Westmead
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

Diagnosis of Duchenne muscular dystrophy, ambulant, steroid naïve.

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026