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Finding the Optimum Regimen for Duchenne Muscular Dystrophy

NCT01603407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2022-08-12

Study results available
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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.

Conditions

Interventions

DRUG

Prednisone

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

DRUG

Prednisone

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

DRUG

Deflazacort

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

Sponsors & Collaborators

  • Newcastle University

    collaborator OTHER

  • University Medical Center Freiburg

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • Robert C. Griggs, MD · University of Rochester

  • Kate Bushby, MD · Newcastle University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01603407 on ClinicalTrials.gov