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: P Nigel Leigh, Michael Swash, Yasuo Iwasaki, Albert Ludolph, Vincent Meininger, Robert G Miller, Hiroshi Mitsumoto, Pamela Shaw, Kunio Tashiro, Leonard Van Den Berg
• Journal: Amyotrophic lateral sclerosis and other motor neuron disorders : official publication of the World Federation of Neurology, Research Group on Motor Neuron Diseases (Amyotroph Lateral Scler Other Motor Neuron Disord) Vol. 5 Issue 2 Pg. 84-98 (Jun 2004) ISSN: 1466-0822 [Print] England
• PMID: 15204010 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Review)

Chemical References

• Oxepins
• dibenzo(b,f)oxepin-10-ylmethyl-methyl-prop-2-ynyl-amine
• Riluzole

Topics

• Amyotrophic Lateral Sclerosis (diagnosis, epidemiology, physiopathology, therapy)
• Animals
• Clinical Trials as Topic (methods, statistics & numerical data)
• Consensus Development Conferences as Topic
• Humans
• Oxepins (therapeutic use)
• Riluzole (therapeutic use)