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NCT01603407 · ClinicalTrials.gov registry record · Phase 3

Finding the Optimum Regimen for Duchenne Muscular Dystrophy

A Phase 3 study, sponsored by University of Rochester.

Completed
Registry status
Phase 3
Development phase
196
Enrollment target

NCT01603407: Completed Phase 3 study, sponsored by University of Rochester.

NCT01603407 is a Phase 3 study that has completed, run by University of Rochester. The registered enrollment target is 196 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01603407, a Phase 3 study, has completed, sponsored by University of Rochester.

COMPLETED
Registry status
Phase 3
Development phase
196 participants
Enrollment target

Study 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.

Primary Outcome

Forced vital capacity was measured during a spirometry test. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test.

Interventions

  • DRUG Prednisone
  • DRUG Deflazacort

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2013-01
Est. Completion 2019-11
Phase Phase 3
University of Rochester

636 total trials

What the finished NCT01603407 record still lists

NCT01603407 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.

NCT01603407 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01603407 about?

NCT01603407 is a clinical study titled "Finding the Optimum Regimen for Duchenne Muscular Dystrophy". 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 th...

What is the current status of trial NCT01603407?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2013-01. Estimated completion is 2019-11.

What interventions are being tested in trial NCT01603407?

The interventions under investigation include: Prednisone (DRUG), Deflazacort (DRUG).

Who is sponsoring clinical trial NCT01603407?

This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01603407's enrollment target sits among peer trials

196 1390th of 2000 higher than 608 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01603407, the US trial registry maintained by the National Library of Medicine. NCT01603407 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.