@article{02905551499142b696b977563fe1d271,
title = "OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial",
abstract = "Objectives: This is the second of a pair of studies designed to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX{\textregistered}) for prophylaxis of headaches in adults with chronic migraine. Methods: PREEMPT 2 was a phase 3 study, with a 24-week, double-blind, placebo-controlled phase, followed by a 32-week, open-label phase. Subjects were randomized (1:1) to injections of onabotulinumtoxinA (155U-195U; n = 347) or placebo (n = 358) every 12 weeks for two cycles. The primary efficacy endpoint was mean change in headache days per 28 days from baseline to weeks 21-24 post-treatment. Results: OnabotulinumtoxinA was statistically significantly superior to placebo for the primary endpoint, frequency of headache days per 28 days relative to baseline (-9.0 onabotulinumtoxinA/-6.7 placebo, p <.001). OnabotulinumtoxinA was significantly favoured in all secondary endpoint comparisons. OnabotulinumtoxinA was safe and well tolerated, with few treatment-related adverse events. Few patients (3.5% onabotulinumtoxinA/1.4% placebo) discontinued due to adverse events. Conclusions: The results of PREEMPT 2 demonstrate that onabotulinumtoxinA is effective for prophylaxis of headache in adults with chronic migraine. Repeated onabotulinumtoxinA treatments were safe and well tolerated.",
keywords = "botulinum toxin A, chronic migraine, prophylaxis",
author = "Diener, {H. C.} and Dodick, {D. W.} and Aurora, {S. K.} and Turkel, {C. C.} and Degryse, {R. E.} and Lipton, {R. B.} and Silberstein, {S. D.} and Brin, {M. F.}",
note = "Funding Information: This study was sponsored by Allergan, Inc., Irvine, CA. Funding Information: HCD has received honoraria for participation in clinical trials, contribution to advisory boards and/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. 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. SKA 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. 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. Acknowledgements Funding Information: The authors 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 trial 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, USA, to provide editorial support in the preparation and styling of this manuscript.",
year = "2010",
month = jul,
doi = "10.1177/0333102410364677",
language = "English (US)",
volume = "30",
pages = "804--814",
journal = "Cephalalgia",
issn = "0333-1024",
publisher = "SAGE Publications Ltd",
number = "7",
}