Amyotrophic lateral sclerosis: lessons in trial design from recent trials

Journal of the Neurological Sciences
G D Borasio

Abstract

The recent history of clinical trials in ALS is marked by a great diversity in trial design. This has limited the comparability of the trial results, and has resulted in intense discussions about which parameters should or should not be evaluated when testing a new drug for ALS. This article discusses, without any claim to completeness, some aspects of trial design in relation to past, ongoing and future ALS trials, including: choice of endpoints, measurement of disease progression, assessment of quality of life, placebo-controlled trials, open-label trials, collaboration with the industry, and methods for investigating mechanisms of action of experimental drugs.

References

May 1, 1995·Journal of the Neurological Sciences·P M BossuytJ M de Jong
Feb 1, 1995·Journal of Neurology, Neurosurgery, and Psychiatry·A Goonetilleke, R J Guiloff
Mar 3, 1994·The New England Journal of Medicine·G BensimonV Meininger
Apr 1, 1993·The American Review of Respiratory Disease·N S Hill
Aug 3, 1996·Lancet·R J GuiloffJ Emami
Feb 1, 1997·Drug and Therapeutics Bulletin

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Citations

Nov 25, 2000·Journal of the Neurological Sciences·O Hurko, F S Walsh
Feb 21, 2002·Neurologic Clinics·G D BorasioR G Miller
Nov 20, 2009·Amyotrophic Lateral Sclerosis : Official Publication of the World Federation of Neurology Research Group on Motor Neuron Diseases·Adriano ChiòUNKNOWN Eurals Consortium
Jun 19, 2004·Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders : Official Publication of the World Federation of Neurology, Research Group on Motor Neuron Diseases·Noah LechtzinUNKNOWN ALS CARE Study Group

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