OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial
- 17 March 2010
- journal article
- research article
- Published by SAGE Publications in Cephalalgia
- Vol. 30 (7), 804-814
- https://doi.org/10.1177/0333102410364677
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.Keywords
This publication has 44 references indexed in Scilit:
- Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferersJournal of Neurology, Neurosurgery & Psychiatry, 2010
- Chronic migraine in the populationNeurology, 2008
- New Appendix Criteria Open for a Broader Concept of Chronic MigraineCephalalgia, 2006
- Chronic Daily HeadacheThe New England Journal of Medicine, 2006
- Primary chronic daily headache and its subtypes in adolescents and adultsNeurology, 2004
- Medication-overuse headache: a worldwide problemThe Lancet Neurology, 2004
- Chronic daily headacheNeurology, 2003
- Prevalence and description of chronic daily headache in the general population in FrancePain, 2003
- Epidemiology of Chronic Daily Headache in the General PopulationHeadache: The Journal of Head and Face Pain, 1999
- Prevalence of Frequent Headache in a Population SampleHeadache: The Journal of Head and Face Pain, 1998