Measuring the rate of progression in Friedreich ataxia: Implications for clinical trial design
Identifieur interne : 001341 ( Istex/Curation ); précédent : 001340; suivant : 001342Measuring the rate of progression in Friedreich ataxia: Implications for clinical trial design
Auteurs : Lisa S. Friedman [États-Unis] ; Jennifer M. Farmer [États-Unis] ; Susan Perlman [États-Unis] ; George Wilmot [États-Unis] ; Christopher M. Gomez [États-Unis] ; Khalaf O. Bushara [États-Unis] ; Katherine D. Mathews [États-Unis] ; S. H. Subramony [États-Unis] ; Tetsuo Ashizawa [États-Unis] ; Laura J. Balcer [États-Unis] ; Robert B. Wilson [États-Unis] ; David R. Lynch [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2010-03-15.
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Abstract
Friedreich ataxia is an autosomal recessive neurodegenerative disorder characterized by ataxia of all four limbs, dysarthria, and arreflexia. A variety of measures are currently used to quantify disease progression, including the Friedreich Ataxia Rating Scale, examiner‐rated functional disability scales, self‐reported activities of daily living and performance measures such as the timed 25‐foot walk, 9‐hole pegboard test, PATA speech test, and low‐contrast letter acuity vision charts. This study examines the rate of disease progression over one and two years in a cohort of 236 Friedreich ataxia patients using these scales and performance measure composites. The Friedreich Ataxia Rating Scale and performance‐measure composites captured disease progression, with a greater sensitivity to change over 2 years than over 1 year. The measures differed in their sensitivity to change and in possible bias. These results help to establish norms for progression in FRDA that can be useful in measuring the long‐term success of therapeutic agents and defining sample‐size calculations for double‐blind clinical trials. © 2010 Movement Disorder Society
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DOI: 10.1002/mds.22912
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Friedman</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Farmer, Jennifer M" sort="Farmer, Jennifer M" uniqKey="Farmer J" first="Jennifer M." last="Farmer">Jennifer M. 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Friedman</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Farmer, Jennifer M" sort="Farmer, Jennifer M" uniqKey="Farmer J" first="Jennifer M." last="Farmer">Jennifer M. Farmer</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Perlman, Susan" sort="Perlman, Susan" uniqKey="Perlman S" first="Susan" last="Perlman">Susan Perlman</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California</wicri:regionArea></affiliation></author><author><name sortKey="Wilmot, George" sort="Wilmot, George" uniqKey="Wilmot G" first="George" last="Wilmot">George Wilmot</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Emory University, Atlanta, Georgia, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Emory University, Atlanta, Georgia</wicri:regionArea></affiliation></author><author><name sortKey="Gomez, Christopher M" sort="Gomez, Christopher M" uniqKey="Gomez C" first="Christopher M." last="Gomez">Christopher M. Gomez</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Minnesota, Minneapolis, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Minnesota, Minneapolis, Minnesota</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Chicago, Chicago, Illinois, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Chicago, Chicago, Illinois</wicri:regionArea></affiliation></author><author><name sortKey="Bushara, Khalaf O" sort="Bushara, Khalaf O" uniqKey="Bushara K" first="Khalaf O." last="Bushara">Khalaf O. Bushara</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Minnesota, Minneapolis, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Minnesota, Minneapolis, Minnesota</wicri:regionArea></affiliation></author><author><name sortKey="Mathews, Katherine D" sort="Mathews, Katherine D" uniqKey="Mathews K" first="Katherine D." last="Mathews">Katherine D. Mathews</name><affiliation wicri:level="1"><mods:affiliation>Departments of Neurology and Pediatrics, University of Iowa, Iowa City, Iowa, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology and Pediatrics, University of Iowa, Iowa City, Iowa</wicri:regionArea></affiliation></author><author><name sortKey="Subramony, S H" sort="Subramony, S H" uniqKey="Subramony S" first="S. H." last="Subramony">S. H. Subramony</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Texas Medical Branch, Galveston, Texas, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Texas Medical Branch, Galveston, Texas</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Mississippi, Jackson, Mississippi, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Mississippi, Jackson, Mississippi</wicri:regionArea></affiliation></author><author><name sortKey="Ashizawa, Tetsuo" sort="Ashizawa, Tetsuo" uniqKey="Ashizawa T" first="Tetsuo" last="Ashizawa">Tetsuo Ashizawa</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Texas Medical Branch, Galveston, Texas, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Texas Medical Branch, Galveston, Texas</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Florida, Gainesville, Florida, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Florida, Gainesville, Florida</wicri:regionArea></affiliation></author><author><name sortKey="Balcer, Laura J" sort="Balcer, Laura J" uniqKey="Balcer L" first="Laura J." last="Balcer">Laura J. Balcer</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Wilson, Robert B" sort="Wilson, Robert B" uniqKey="Wilson R" first="Robert B." last="Wilson">Robert B. Wilson</name><affiliation wicri:level="1"><mods:affiliation>Department of Pathology and Laboratory Medicine, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pathology and Laboratory Medicine, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Lynch, David R" sort="Lynch, David R" uniqKey="Lynch D" first="David R." last="Lynch">David R. Lynch</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Pediatrics, School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Children's Hospital of Philadelphia, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-03-15">2010-03-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="426">426</biblScope><biblScope unit="page" to="432">432</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">A06CB388546EB8D4B4B45FDF7F94DCE8AC0A1CCF</idno><idno type="DOI">10.1002/mds.22912</idno><idno type="ArticleID">MDS22912</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>ataxia</term><term>clinical neurology examination</term><term>mitochondrial disorder</term><term>natural history study</term><term>trinucleotide repeat disease</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Friedreich ataxia is an autosomal recessive neurodegenerative disorder characterized by ataxia of all four limbs, dysarthria, and arreflexia. A variety of measures are currently used to quantify disease progression, including the Friedreich Ataxia Rating Scale, examiner‐rated functional disability scales, self‐reported activities of daily living and performance measures such as the timed 25‐foot walk, 9‐hole pegboard test, PATA speech test, and low‐contrast letter acuity vision charts. This study examines the rate of disease progression over one and two years in a cohort of 236 Friedreich ataxia patients using these scales and performance measure composites. The Friedreich Ataxia Rating Scale and performance‐measure composites captured disease progression, with a greater sensitivity to change over 2 years than over 1 year. The measures differed in their sensitivity to change and in possible bias. These results help to establish norms for progression in FRDA that can be useful in measuring the long‐term success of therapeutic agents and defining sample‐size calculations for double‐blind clinical trials. © 2010 Movement Disorder Society</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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