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A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy — BRAVE  

Muscular Dystrophy, Duchenne Clinical Trial

Official title:
A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy

Clinical Trial Summary

This is a multicenter, double blind, placebo controlled, multiple dose study to examine the safety and efficacy of MNK-1411 in male subjects 4 to 8 years of age (inclusive) with Duchenne Muscular Dystrophy (DMD).

Clinical Trial Description

The main purpose of this study is to determine the effect of MNK-1411 on motor function in participants with Duchenne Muscular Dystrophy (DMD). Information is collected only from caretakers who are fluent in English, using the Pediatric Outcomes Data Collection Instrument (PODCI). The PODCI is a validated 86-question instrument completed by the parent or legal guardian of children 2 to 10 years of age to assess a variety of health outcome measures (Uzark et al, 2012). This study will only collect information for the PODCI domains of sports and physical functioning and transfer/basic mobility. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03400852
Study type Interventional
Source Mallinckrodt
Contact
Status Terminated
Phase Phase 2
Start date July 27, 2018
Completion date February 25, 2020
View Details
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