期刊
AMYOTROPHIC LATERAL SCLEROSIS
卷 5, 期 2, 页码 84-98出版社
INFORMA HEALTHCARE
DOI: 10.1080/14660820410020187
关键词
amyotrophic lateral sclerosis; motor neuron disease; clinical trials; endpoints; TCH346
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 comedication with pre-existing treatment in trial design, are discussed.
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