@article{ea4325868b81480caf0cc3fe6741abde,
title = "OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial",
abstract = "Objectives: This is the first of a pair of studies designed to assess efficacy, safety and tolerability of onabotulinumtoxinA (BOTOX{\textregistered}) as headache prophylaxis in adults with chronic migraine. Methods: The Phase III REsearch Evaluating Migraine Prophylaxis Therapy 1 (PREEMPT 1) is a phase 3 study, with a 24-week, double-blind, parallel-group, placebo-controlled phase followed by a 32-week, open-label phase. Subjects were randomized (1:1) to injections every 12 weeks of onabotulinumtoxinA (155 U-195 U; n = 341) or placebo (n = 338) (two cycles). The primary endpoint was mean change from baseline in headache episode frequency at week 24. Results: No significant between-group difference for onabotulinumtoxinA versus placebo was observed for the primary endpoint, headache episodes (-5.2 vs.-5.3; p = 0.344). Large within-group decreases from baseline were observed for all efficacy variables. Significant between-group differences for onabotulinumtoxinA were observed for the secondary endpoints, headache days (p =.006) and migraine days (p = 0.002). OnabotulinumtoxinA was safe and well tolerated, with few treatment-related adverse events. Few subjects discontinued due to adverse events. Conclusions: There was no between-group difference for the primary endpoint, headache episodes. However, significant reductions from baseline were observed for onabotulinumtoxinA for headache and migraine days, cumulative hours of headache on headache days and frequency of moderate/severe headache days, which in turn reduced the burden of illness in adults with disabling chronic migraine.",
keywords = "botulinum toxin A, chronic migraine, prophylaxis",
author = "Aurora, {S. K.} and Dodick, {D. W.} and Turkel, {C. C.} and Degryse, {R. E.} and Silberstein, {S. D.} and Lipton, {R. B.} and Diener, {H. C.} and Brin, {M. F.}",
note = "Funding Information: This study was sponsored by Allergan, Inc., Irvine, CA, USA. Funding Information: SKA has received grants and research support from Advanced Bionics, Alexza, Allergan, Capnia, GlaxoSmithKline, MAP pharmaceuticals, Merck, Ortho-McNeil, Neuralieve, NuPathe and Takeda. She is a consultant for Ortho-McNeil, Merck, GlaxoSmithKline, Allergan, Neuralieve, NuPathe and MAP Pharmaceuticals. She has also received honoraria from Merck, GlaxoSmithKline, Kowa, NuPathe and Ortho-McNeil. DWD has received honoraria from Allergan, Merck, Neuralieve, Coherex, Kowa, Minster, NeurAxon, H Lundbeck, Endo, Pfizer, Nupathe and MAP Pharmaceuticals, in addition to being a consultant to and on the advisory board of these pharmaceutical companies. He has also received funding from Advanced Neurostimulation Systems, St. Jude Medical Center and Medtronic. CCT, RED and MFB are employees of Allergan, and own stock in the company. SDS and RBL have received honoraria and research funding from Allergan, in addition to being consultants to and on the advisory board of Allergan. HCD has received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from Addex Pharma, Allergan, Almirall, AstraZeneca, Bayer Vital, Berlin Chemie, CoLucid, Bohringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Lilly, La Roche, 3M Medica, Minster, MSD, Novartis, Johnson & Johnson, Pierre Fabre, Pfizer, Schaper and Brummer, Sanofi-Aventis and Weber & Weber. He has also received financial support for research projects from Allergan, Almirall, AstraZeneca, Bayer, GlaxoSmithKline, Janssen-Cilag, and Pfizer. Headache research at the Department of Neurology in Essen, where HCD is Professor, is supported by the German Research Council (DFG), the German Ministry of Education and Research (BMBF), and the European Union. Acknowledgements Funding Information: The authors would like to thank the patients who participated in the studies and their families. We also thank the Regional Lead Coordinating Investigators and Allergan Global Clinical Operations for their support, principal investigators and their staff for conducting the trials (PREEMPT 1 and PREEMPT 2) and current and past BOTOX{\textregistered} Headache Development advisory board members for their input and intellectual contributions to the development and advancement of the BOTOX{\textregistered} clinical development program. We would like to thank Allergan, Inc., for funding IntraMed Educational Group, New York, NY, to provide editorial support in the preparation and styling of this manuscript. Copyright: Copyright 2010 Elsevier B.V., All rights reserved.",
year = "2010",
month = jul,
doi = "10.1177/0333102410364676",
language = "English (US)",
volume = "30",
pages = "793--803",
journal = "Cephalalgia",
issn = "0333-1024",
publisher = "SAGE Publications Ltd",
number = "7",
}