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9 - The clinical trial in efficacy research in neurological diseases
from Part I - Quantitative methods in clinical neurology
- By Jan van Gijn, M. Vermeulen
Albert Hofman, Erasmus Universiteit Rotterdam, Richard Mayeux, Columbia University, New York
Book:

Investigating Neurological Disease

Published online:

29 September 2009

Print publication:

30 August 2001, pp 113-134
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Summary

This chapter starts with some issues that apply to clinical trials in general: pragmatic versus explanatory trials, role of sponsoring industries, methods of randomization, and double blind versus single blind design. It describes the measurement of outcome in neurology. The chapter covers certain neurological disorders such as stroke, Parkinson's disease, multiple sclerosis (MS), polyneuropathy, migraine, and epilepsy. Several phases can be distinguished in the evaluation of therapy. Phase I studies often investigate what the safe dose range is. Phase II studies are carried out in volunteers or in patients. Phase III studies are clinical studies in which the effectiveness suggested by phase II studies is put to the test. Phase IV studies are planned postmarketing studies. The most well-known and widely used clinical measure for measuring outcome in clinical trials of patients with MS is the Kurtzke Extended Disability Status Scale (EDSS).