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New Evidence Published in Muscle and Nerve on Measuring 6-Minute Walk Distance in Duchenne Muscular Dystrophy
Date:8/26/2013

n Belgium and Italy. All three data sets show a similar change in 6-minute walk distance over one year as a measure of disease progression."

The 6MWT was originally developed as an integrated assessment of cardiac, respiratory, circulatory and muscular capacity, and it has previously been used as a primary outcome in a number of clinical studies to support the regulatory approval of treatments for a number of other neuromuscular disorders. In a prior short-term study (McDonald et al 2010), the 6MWT was established as a feasible, safe and reliable outcome measure of walking ability in boys with DMD, who have not yet transitioned to full-time wheelchair use. A follow-up longitudinal study concluded that changes in 6MWD depend on stride length and age. Improvements in 6MWD were observed in both healthy subjects and patients with DMD <7 years of age, attributed to maturational development. In contrast, the walking ability of older DMD patients (≥7 years of age) worsened, while the walking ability of older healthy subjects (≥7 years of age) tended to either increase or remain stable. Subsequent studies have confirmed this observation and also demonstrated that 6MWD correlates with other clinical endpoints in DMD, such as timed function tests and the North Star Ambulatory Assessment (NSAA), as well as established patient-reported outcomes of physical function.

"In our Phase 2b Duchenne muscular dystrophy trial, we did not have any natural history to guide our inclusion criteria. The patient population was quite heterogeneous ranging in age from 5 to 20 years old and the baseline 6-minute walk distance ranged from 75 meters to 554 meters," stated Stuart W. Peltz, Ph.D., Chief Executive Officer at PTC Therapeutics, Inc. "Armed with a better understanding of the natural history of the disease, the enrollment criteria for our ongoing Phase 3 trial now enriches the pat
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SOURCE PTC Therapeutics, Inc.
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