Literature DB >> 23677550

The cooperative international neuromuscular research group Duchenne natural history study--a longitudinal investigation in the era of glucocorticoid therapy: design of protocol and the methods used.

Craig M McDonald1, Erik K Henricson, R Ted Abresch, Jay J Han, Diana M Escolar, Julaine M Florence, Tina Duong, Adrienne Arrieta, Paula R Clemens, Eric P Hoffman, Avital Cnaan.   

Abstract

UNLABELLED: Contemporary natural history data in Duchenne muscular dystrophy (DMD) is needed to assess care recommendations and aid in planning future trials.
METHODS: The Cooperative International Neuromuscular Research Group (CINRG) DMD Natural History Study (DMD-NHS) enrolled 340 individuals, aged 2-28 years, with DMD in a longitudinal, observational study at 20 centers. Assessments obtained every 3 months for 1 year, at 18 months, and annually thereafter included: clinical history; anthropometrics; goniometry; manual muscle testing; quantitative muscle strength; timed function tests; pulmonary function; and patient-reported outcomes/health-related quality-of-life instruments.
RESULTS: Glucocorticoid (GC) use at baseline was 62% present, 14% past, and 24% GC-naive. In those ≥6 years of age, 16% lost ambulation over the first 12 months (mean age 10.8 years).
CONCLUSIONS: Detailed information on the study methodology of the CINRG DMD-NHS lays the groundwork for future analyses of prospective longitudinal natural history data. These data will assist investigators in designing clinical trials of novel therapeutics.
Copyright © 2013 Wiley Periodicals, Inc.

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Year:  2013        PMID: 23677550      PMCID: PMC4147958          DOI: 10.1002/mus.23807

Source DB:  PubMed          Journal:  Muscle Nerve        ISSN: 0148-639X            Impact factor:   3.217


  97 in total

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Journal:  Muscle Nerve       Date:  2007-01       Impact factor: 3.217

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Journal:  Phys Ther       Date:  1985-09

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  69 in total

1.  Prednisone/prednisolone and deflazacort regimens in the CINRG Duchenne Natural History Study.

Authors:  Luca Bello; Heather Gordish-Dressman; Lauren P Morgenroth; Erik K Henricson; Tina Duong; Eric P Hoffman; Avital Cnaan; Craig M McDonald
Journal:  Neurology       Date:  2015-08-26       Impact factor: 9.910

2.  Cooperative International Neuromuscular Research Group Duchenne Natural History Study demonstrates insufficient diagnosis and treatment of cardiomyopathy in Duchenne muscular dystrophy.

Authors:  Christopher Spurney; Reiko Shimizu; Lauren P Morgenroth; Hanna Kolski; Heather Gordish-Dressman; Paula R Clemens
Journal:  Muscle Nerve       Date:  2014-05-14       Impact factor: 3.217

3.  Association Study of Exon Variants in the NF-κB and TGFβ Pathways Identifies CD40 as a Modifier of Duchenne Muscular Dystrophy.

Authors:  Luca Bello; Kevin M Flanigan; Robert B Weiss; Pietro Spitali; Annemieke Aartsma-Rus; Francesco Muntoni; Irina Zaharieva; Alessandra Ferlini; Eugenio Mercuri; Sylvie Tuffery-Giraud; Mireille Claustres; Volker Straub; Hanns Lochmüller; Andrea Barp; Sara Vianello; Elena Pegoraro; Jaya Punetha; Heather Gordish-Dressman; Mamta Giri; Craig M McDonald; Eric P Hoffman
Journal:  Am J Hum Genet       Date:  2016-10-13       Impact factor: 11.025

4.  Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy.

Authors:  Daniela J Conrado; Jane Larkindale; Alexander Berg; Micki Hill; Jackson Burton; Keith R Abrams; Richard T Abresch; Abby Bronson; Douglass Chapman; Michael Crowther; Tina Duong; Heather Gordish-Dressman; Lutz Harnisch; Erik Henricson; Sarah Kim; Craig M McDonald; Stephan Schmidt; Camille Vong; Xiaoxing Wang; Brenda L Wong; Florence Yong; Klaus Romero
Journal:  J Pharmacokinet Pharmacodyn       Date:  2019-05-24       Impact factor: 2.745

5.  Interleukin 1 Receptor-Like 1 Protein (ST2) is a Potential Biomarker for Cardiomyopathy in Duchenne Muscular Dystrophy.

Authors:  Julia Anderson; Haeri Seol; Heather Gordish-Dressman; Yetrib Hathout; Christopher F Spurney
Journal:  Pediatr Cardiol       Date:  2017-08-18       Impact factor: 1.655

6.  Longitudinal Evaluation of Muscle Composition Using Magnetic Resonance in 4 Boys With Duchenne Muscular Dystrophy: Case Series.

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Journal:  Phys Ther       Date:  2015-01-15

7.  DMD genotypes and loss of ambulation in the CINRG Duchenne Natural History Study.

Authors:  Luca Bello; Lauren P Morgenroth; Heather Gordish-Dressman; Eric P Hoffman; Craig M McDonald; Sebahattin Cirak
Journal:  Neurology       Date:  2016-06-24       Impact factor: 9.910

8.  DMD mutation and LTBP4 haplotype do not predict onset of left ventricular dysfunction in Duchenne muscular dystrophy.

Authors:  Charlotte S Van Dorn; Michael D Puchalski; Hsin-Yi Weng; Steven B Bleyl; Russell J Butterfield; Richard V Williams
Journal:  Cardiol Young       Date:  2018-05-16       Impact factor: 1.093

9.  The cooperative international neuromuscular research group Duchenne natural history study: glucocorticoid treatment preserves clinically meaningful functional milestones and reduces rate of disease progression as measured by manual muscle testing and other commonly used clinical trial outcome measures.

Authors:  Erik K Henricson; R Ted Abresch; Avital Cnaan; Fengming Hu; Tina Duong; Adrienne Arrieta; Jay Han; Diana M Escolar; Julaine M Florence; Paula R Clemens; Eric P Hoffman; Craig M McDonald
Journal:  Muscle Nerve       Date:  2013-05-06       Impact factor: 3.217

Review 10.  Current and Emerging Therapies for Duchenne Muscular Dystrophy.

Authors:  Megan Crone; Jean K Mah
Journal:  Curr Treat Options Neurol       Date:  2018-06-23       Impact factor: 3.598

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