OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial
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- HC Diener
- University of Essen, Germany.
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- DW Dodick
- Mayo Clinic Arizona, USA.
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- SK Aurora
- Swedish Neuroscience Institute, USA.
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- CC Turkel
- Allergan, Inc., USA.
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- RE DeGryse
- Allergan, Inc., USA.
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- RB Lipton
- Albert Einstein College of Medicine, USA.
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- SD Silberstein
- Thomas Jefferson University, USA.
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- MF Brin
- Allergan, Inc., USA.
説明
<jats:p>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.</jats:p><jats:p>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.</jats:p><jats:p>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.</jats:p><jats:p>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.</jats:p>
収録刊行物
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- Cephalalgia
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Cephalalgia 30 (7), 804-814, 2010-03-17
SAGE Publications