J Headache Pain (2011) 12:137 138
DOI 10.1007/s10194-011-0334-4
EDITORIAL COMMENTARY
Reply: Clinical trials on onabotulinumtoxinA for the treatment
of chronic migraine
" "
Sheena Aurora Hans-Christoph Diener
David Dodick
Received: 14 December 2010 / Accepted: 30 December 2010 / Published online: 3 April 2011
Ó The Author(s) 2011. This article is published with open access at Springerlink.com
Dr. Russell raises important points regarding the diagnostic Dr. Russell s assertion, additional data are needed to
criteria for chronic migraine (CM) and medication overuse determine which of these patients meet criteria for MOH.
headache (MOH). We agree that the definitions for these The decision not to exclude patients overusing acute
entities have posed challenges for the past two decades. medication was made based on consultation with members
The ICHD-2 diagnostic criteria for CM and MOH were of the Task Force of the International Headache Society
evolving as the PREEMPT clinical trial program was Clinical Trials Subcommittee, and is consistent with their
developed and launched. In the original ICHD-2 definition published guidelines for controlled trials of prophylactic
of MOH, remission of headache [15 days per month fol- treatment of CM in adults [2]. These guidelines reflect the
lowing discontinuation of medication was required. As a high prevalence of medication overuse in CM patients, and
consequence, the diagnosis could be assigned only to recommend the inclusion and stratification of these patients
individuals who no longer had the condition. The ICHD-2R in clinical studies. In line with these guidelines, patients
definition of MOH no longer requires remission after with medication overuse were stratified at randomization in
withdrawal [1]. A history of headache escalation during a the PREEMPT clinical program [3]. If patients with med-
period of medication overuse is still required by ICHD-2R, ication overuse are excluded, we lose the opportunity to
though in the vast majority of patients it is not possible to address the benefits of treatment in a large group with
reliably determine if medication overuse is a cause or a disabling headache and an unmet treatment need. Results
consequence of increasing headache frequency. Moreover, from an independent clinic-based study designed to assess
contrary to conventional wisdom, there is no evidence from the overlap between ICHD-2R and other proposed diag-
controlled trials that the withdrawal of acute medications nostic criteria for CM (including PREEMPT enrollment
alone, in those who overuse them, leads to the long-term criteria) determined that there was significant overlap
remission of headache. between these definitions [4].
In the PREEMPT program, patients who otherwise met We completely agree with Dr. Russell that subgroup
study criteria for CM were not excluded if they were analyses are warranted. Data have been presented on the
making frequent use of acute medication. Contrary to medication overuse subpopulation demonstrating efficacy
of onabotulinumtoxinA compared to placebo on multiple
headache symptom measures [5], and a manuscript is in
On behalf of the PREEMPT Chronic Migraine Study Group. progress. Additional post hoc analysis of subgroup popu-
lations, such as those PREEMPT patients who have taken
S. Aurora
prior prophylaxis, are currently underway and will also be
Swedish Neuroscience Institute, Seattle, WA, USA
detailed in future publications.
H.-C. Diener We believe the PREEMPT study enrolled patients rep-
University of Essen, Essen, Germany
resentative of the CM population and that the results of the
program have greater generalizability because of our
D. Dodick (&)
inclusion criteria. These studies show that onabotulinum-
Mayo Clinic Arizona, Phoenix, AZ, USA
e-mail: Dodick.David@mayo.edu toxinA treatment compared to placebo resulted in clinically
123
138 J Headache Pain (2011) 12:137 138
meaningful outcomes; significantly reduced headache fre- Schoenen J, Silberstein SD, Steiner TJ (2006) New appendix
criteria open for a broader concept of chronic migraine. Cepha-
quency; and significantly improved functioning, vitality,
lalgia 26:742 746
and overall quality of life [3]. As clinicians dedicated to the
2. Silberstein S, Tfelt-Hansen P, Dodick DW, Limmroth V, Lipton
care of patients with headache, identification and success- RB, Pascual J, Wang SJ (2008) Guidelines for controlled trials of
prophylactic treatment of chronic migraine in adults. Cephalalgia
ful prophylactic treatment of this highly disabled patient
28:484 495
population is our main objective.
3. Dodick DW, Turkel CC, Degryse RE, Aurora SK, Silberstein SD,
Lipton RB, Diener HC, Brin MF, on behalf of the PREEMPT
Sincerely,
Chronic Migraine Study Group (2010) OnabotulinumtoxinA for
Sheena Aurora, MD
treatment of chronic migraine: pooled results from the double-
Hans-Christoph Diener, MD
blind, randomized, placebo-controlled phases of the PREEMPT
David Dodick, MD
clinical program. Headache 50:921 963
4. Bigal M, Rapoport A, Sheftell F, Tepper S, Lipton R (2007) The
On behalf of the PREEMPT Chronic Migraine Study
International Classification of Headache Disorders revised criteria
Group
for chronic migraine-field testing in a headache specialty clinic.
Cephalalgia 27:230 234
Open Access This article is distributed under the terms of the
5. Silberstein SD, Blumenfeld AM, Cady RK, Turner IM, Sirimanne
Creative Commons Attribution License which permits any use, dis-
M, Degryse RE, Turkel CC (2009) OnabotulinumtoxinA for
tribution and reproduction in any medium, provided the original
treatment of chronic migraine: analysis of the PREEMPT chronic
author(s) and source are credited.
migraine subgroup who were overusing acute headache medica-
tions at baseline. In: 14th international headache congress,
Philadelphia, PA, September 2009
References
1. Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby
PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F,
123
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