HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Figures Only Full Text Correspondence: Submit a response Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Lipton, R. B. Articles by Stewart, W. F. Search for Related Content PubMed PubMed Citation Articles by Lipton, R. B. Articles by Stewart, W. F.

Neurology supplements are not peer-reviewed.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.

Clinical trials of acute treatments for migraine including multiple attack studies of pain, disability, and health-related quality of life

From the Departments of Neurology (Dr. Lipton and Dr. Bigal) and Epidemiology and Social Medicine (Dr. Lipton), Albert Einstein College of Medicine, Bronx, New York; The New England Center for Headache (Dr. Bigal), Stamford, Connecticut; Advance PCS, Hunt-Valley, MD (Dr. Stewart); and Department of Epidemiology (Dr. Stewart), The Johns Hopkins University, Baltimore, Maryland.

Address correspondence and reprint requests to Dr. Richard B. Lipton, Albert Einstein College of Medicine, Department of Neurology, 1300 Morris Park Avenue, Bronx, NY, 10461; e-mail: Rlipton{at}aecom.yu.edu

Because migraine has features in common with episodic monophasic pain disorders (such as postoperative or posttraumatic pain) and with chronic pain disorders (such as osteoarthritis or painful neuropathy), it is often considered an episodic-chronic disorder. In clinical practice, the chronic aspects of migraine are addressed using preventive treatment strategies, while the episodic attacks are addressed by acute treatment strategies. Acute treatment strategies have generally been supported by clinical trial designs that focus on single attacks, whereas preventive treatment strategies evaluate multiple attacks over a period of time. Recently, long-term acute treatment clinical designs have emerged that may inform the design of clinical trials for other episodic-chronic disorders. After reviewing traditional acute treatment clinical trials, we focus here on study methods designed to evaluate treatment and management strategies for migraine over multiple attacks, including outcomes that assess the chronic-episodic nature of migraine (such as headache recurrence and consistency of relief), rather than relief from single attacks. We also discuss end points that reflect the treatment needs of patients, such as disability and health-related quality of life. The traditional randomized controlled trial designed to assess treatment efficacy for a single attack is insufficient to address the broader set of issues that arise in clinical practice. We consider clinical trials strategies designed to address the more complex clinical and policy requirements for meeting the needs of those with migraine.

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: RBL has consulted for, received honoraria from, or conducted research funded by Abbot Laboratories, Allergan, Astra Zeneca, Bristol Meyers Squib, Elan, Glaxo Smith Kline, Johnson and Johnson, Pharmacia and Pfizer. The sponsor has provided MEB with grant support and other honoraria (in excess of $10,000) during his professional career. WFS has disclosed no financial relationship with the sponsor.

This article has been cited by other articles:

				A. M. Rapoport, N. T. Mathew, S. D. Silberstein, D. Dodick, S. J. Tepper, F. D. Sheftell, and M. E. Bigal Zolmitriptan nasal spray in the acute treatment of cluster headache: A double-blind study Neurology, August 28, 2007; 69(9): 821 - 826. [Abstract] [Full Text] [PDF]

				I. Lalani Emerging subspecialties in neurology: Pain medicine Neurology, October 24, 2006; 67(8): 1522 - 1523. [Full Text] [PDF]