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NEUROLOGY 2005;65:S66-S73
© 2005 American Academy of Neurology

Neurology supplements are not peer-reviewed. Information contained in Neurology supplements represent the opinions of the authors and are not endorsed by nor do they reflect the views of the American Academy of Neurology, Editor-in-Chief, or Associate Editors of Neurology.

Mechanisms of neuropathic pain and their implications for the design of clinical trials

Michael C. Rowbotham, MD

From the UCSF Pain Clinical Research Center, Department of Neurology, University of California, San Francisco, California.

Address correspondence and reprint requests to Dr. Michael C. Rowbotham, UCSF Pain Clinical Research Center, 1701 Divisadero Street, Suite 480, San Francisco, CA 94115; e-mail: mcrwind{at}itsa.ucsf.edu

A mechanism-based approach to treatment is alluring, but numerous practical problems impede its implementation. Although many new therapies have entered clinical trials, and randomized controlled trials have become larger and more sophisticated, pre-trial testing of underlying pain mechanisms is almost never performed for reasons of cost, risk to subjects, time required, and validation of the techniques used. Most registration clinical trials are performed in patients with post-herpetic neuralgia and painful diabetic neuropathy, but without more information on pain mechanisms, it remains uncertain how fully results in those two disorders can be generalized to patients with other types of chronic neuropathic pain. Examples of study designs and potential solutions are presented.


Publication of this supplement was supported in part by an educational grant from Pfizer Inc to the Office of Professional Education, University of Rochester School of Medicine and Dentistry.

Disclosure: The sponsor has provided the author with the following: an honorarium for his participation in this project, grant support, and other honoraria during his professional career.




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