ALS clinical trials: Do enrolled patients accurately represent the ALS population?

A. Chiò, A. Canosa, S. Gallo, S. Cammarosano, C. Moglia, G. Fuda, A. Calvo, G. Mora

Research output: Contribution to journalArticle

Abstract

Objective: To assess the effect of eligibility criteria in amyotrophic lateral sclerosis (ALS) clinical trials on the representativeness of the enrolled population. Methods: Patients enrolled in 8 placebo-controlled clinical trials in our ALS center from 2003 to 2008 were compared 1) to the patients included a prospective epidemiologic register (Piemonte and Valle d'Aosta register for ALS, PARALS) in the same period and 2) the subset of PARALS patients who met the usual criteria for inclusion in clinical trials (PARALS-ct) (definite, probable, probable laboratory-supported ALS; age between 18 and 75 years; disease duration

Original languageEnglish
Pages (from-to)1432-1437
Number of pages6
JournalNeurology
Volume77
Issue number15
DOIs
Publication statusPublished - Oct 11 2011

ASJC Scopus subject areas

  • Clinical Neurology
  • Arts and Humanities (miscellaneous)

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  • Cite this

    Chiò, A., Canosa, A., Gallo, S., Cammarosano, S., Moglia, C., Fuda, G., Calvo, A., & Mora, G. (2011). ALS clinical trials: Do enrolled patients accurately represent the ALS population? Neurology, 77(15), 1432-1437. https://doi.org/10.1212/WNL.0b013e318232ab9b