Cephalalgia. 2010 Jul;30(7):804-14. doi: 10.1177/0333102410364677. Epub 2010 Mar 17.
OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial.
Becker WJ, Blumenfeld A, Cutrer FM, Gendolla A, Lay C, Martin V, Relja M, Schim JD, Smith TR, Ward TW, Winner P, Abbas J, Ali S, Bahia B, Balyakin S, Blanco A, Boodhoo T, Brown A, Chan R, Chin R, Demos G, Dick C, Drake D, Fainaru I, Fitch L, Gilbert M, Gonzales R, Ho A, Hook D, Huynh C, Lei X, Marruffo K, Miller-Messana MA, Nguyen D, Nguyen D, Patel S, Phomma M, Quimpo S, Rask A, Reyes C, Robinson MA, Roth J, Shin R, Sirimanne M, Taylor B, Tse A, VanDenburgh A, Vu K, Writer C, Reto Agosti, Becker WJ, Bilchik T, Blonsky E, Bowman S, Brownstone P, Boudreau GP, Cady R, Cook A, Diener HC, Edwards K, Elkind A, Elliott M, Erlington GM, Evers S, Ferencz G, Files J, Finkel A, Finkelstein I, Frishberg B, Galvez-Jimenez N, Gawel M, Goadsby P, Gobel H, Goldstein E, Grosberg B, Hinton J Jr, Hogan P, Janculjak D, Johnson C, Kothari M, Krusz JC, Langler K, Lucas S, Mazzeo P, McCarren D, Miller TA, Morse M, Nicolas J, Nikpey P, O'Carroll CP, Pfaffenrath V, Pugach N, Relja M, Reuter U, Ribeiro M, Richardson P, Rivner M, Sacco S, Sandor P, Saper J, Sitwell L, Smith T, Sommer C, Spierings E, Stein M, Straube A, Taylor F, Taylor M, Tepper S, Turner I, Veilleux M, Vurdelja R, Walker J, Weissman J, Weatherby S, Wilson MC, Wymer J, Aurora SK, Becker WJ, Blumenfeld A, Burstein R, Dahlof C, Diener HC, Dodick DM, Fox AW, Freitag FG, Lipton RB, Mathew NT, Osterhaus J, Pascual J, Saper JR, Silberstein SD, Welch KM, Winner P.
Source
University of Essen, Germany. hans.diener@uni-duisburg-essen.de
Abstract
OBJECTIVES:
This is the second of a pair of studies designed to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX) 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.
- PMID:
- 20647171
- [PubMed - indexed for MEDLINE]
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