title: Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial.
abstract: In November 2002, an advisory board meeting was convened by Novartis Pharma to provide recommendations and rationale for clinical trials designed to evaluate new treatments, such as TCH346, for amyotrophic lateral sclerosis (ALS). In terms of selecting appropriate outcome measures, the panel recommended the use of the ALS Functional Rating Scale (ALSFRS-R) to measure primary endpoints. A review of other key issues in this area including regional variations in the epidemiology, diagnosis and management of ALS, defining patient populations and doses of trial medication, and accommodating the likelihood of co-medication with pre-existing treatment in trial design, are discussed.
authors.affiliation: Department of Neurology, Institute of Psychiatry, London, UK. spgtpni@iop.kcl.ac.uk
authors.forename: P Nigel
authors.initials: PN
authors.lastname: Leigh
authors.forename: Michael
authors.initials: M
authors.lastname: Swash
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Iwasaki
authors.forename: Albert
authors.initials: A
authors.lastname: Ludolph
authors.forename: Vincent
authors.initials: V
authors.lastname: Meininger
authors.forename: Robert G
authors.initials: RG
authors.lastname: Miller
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Mitsumoto
authors.forename: Pamela
authors.initials: P
authors.lastname: Shaw
authors.forename: Kunio
authors.initials: K
authors.lastname: Tashiro
authors.forename: Leonard
authors.initials: L
authors.lastname: Van Den Berg
mesh_terms: D000690:Amyotrophic Lateral Sclerosis / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy; D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003245:Consensus Statements as Topic; D006801:Humans; D010082:Oxepins / Q000627:therapeutic use; D019782:Riluzole / Q000627:therapeutic use
chemical_list: D010082:Oxepins; C111178:dibenzo(b,f)oxepin-10-ylmethyl-methyl-prop-2-ynyl-amine; D019782:Riluzole