CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
Prednisone +2 moredrug
Likely dose
Prednisone 0.75 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01603407
NCT01603407Phase 3Completed
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Duchenne Muscular Dystrophy: Double-blind Randomized Trial to Find Optimum Steroid Regimen

University of Rochester·interventional·Posted May 23, 2012·Updated Aug 12, 2022

In Brief

A Phase 3 clinical trial evaluating Prednisone and Deflazacort for Duchenne Muscular Dystrophy. Completed, enrolled 196 participants across 32 sites in 5 countries.

Detailed Summary

The Finding the Optimum Regimen for Duchenne Muscular Dystrophy (FOR DMD) study will compare three ways of giving corticosteroids to boys with Duchenne muscular dystrophy (DMD) to determine which of the three ways increases muscle strength the most, and which causes the fewest side effects. Using the results of this study, the investigators aim to provide patients and families with clearer information about the best way to take these drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesCanada, Germany, Italy, United Kingdom, United States
CollaboratorsNewcastle University, University Medical Center Freiburg, National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 23, 2012
Enrollment StartJan 1, 2013
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 14.1 years ago

Interventions

Prednisonedrug

daily prednisone (0.75 mg/kg/day) tablets for 36-60 months

Prednisonedrug

intermittent prednisone (0.75 mg/kg/day, 10 days on, 10 days off) tablets for 36 to 60 months

Deflazacortdrug

daily deflazacort (0.9 mg/kg/day) tablets for 36-60 months