The DOI matches its Crossref record; 5 of the 5 references it cites were found in a registry or an index.
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®) 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.
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Cites
A six-item short-form survey for measuring headache impact: The HIT-6™
Kosinski, M., Bayliss, M. S., Bjorner, J. B., Ware, J. E., Garber, W. H., Batenhorst, A., Cady, R., Dahlöf, C. G. H., Dowson, A., & Tepper, S. (2003) · Quality of Life Research · doi:10.1023/a:1026119331193 · Cited by 1,376
New Appendix Criteria Open for a Broader Concept of Chronic Migraine
Olesen, J., Bousser, M.-G., Diener, H.-C., Dodick, D., First, M., Goadsby, P., Göbel, H., Lainez, M., Lance, J., Lipton, R., et al. (2006) · Cephalalgia · doi:10.1111/j.1468-2982.2006.01172.x · Cited by 909
Self-citationMedication-overuse headache: a worldwide problem
Diener, H.-C., & Limmroth, V. (2004) · The Lancet Neurology · doi:10.1016/s1474-4422(04)00824-5 · Cited by 455
Self-citationDevelopment and Validation of the Migraine‐Specific Quality of Life Questionnaire
Jhingran, P., Osterhaus, J. T., Miller, D. W., Lee, J. T., & Kirchdoerfer, L. (1998) · Headache: The Journal of Head and Face Pain · doi:10.1046/j.1526-4610.1998.3804295.x · Cited by 252
Topiramate in the Treatment of Chronic Migraine
Silvestrini, M., Bartolini, M., Coccia, M., Baruffaldi, R., Taffi, R., & Provinciali, L. (2003) · Cephalalgia · doi:10.1046/j.1468-2982.2003.00592.x · Cited by 162
Cited by
Tepper, S., Ashina, M., Reuter, U., Brandes, J. L., Doležil, D., Silberstein, S., Winner, P., Leonardi, D., Mikol, D., & Lenz, R. (2017) · The Lancet Neurology · doi:10.1016/s1474-4422(17)30083-2 · Cited by 722
Self-citationTassorelli, C., Diener, H.-C., Dodick, D. W., Silberstein, S. D., Lipton, R. B., Ashina, M., Becker, W. J., Ferrari, M. D., Goadsby, P. J., Pozo-Rosich, P., et al. (2018) · Cephalalgia · doi:10.1177/0333102418758283 · Cited by 388
Self-citationVandervorst, F., Van Deun, L., Van Dycke, A., Paemeleire, K., Reuter, U., Schoenen, J., & Versijpt, J. (2021) · The Journal of Headache and Pain · doi:10.1186/s10194-021-01335-2 · Cited by 121
Lipton, R. B., Rosen, N. L., Ailani, J., DeGryse, R. E., Gillard, P. J., & Varon, S. F. (2016) · Cephalalgia · doi:10.1177/0333102416652092 · Cited by 85
Self-citationUpdate of chronic tension-type headache
Yu, S., & Han, X. (2015) · Current Pain and Headache Reports · doi:10.1007/s11916-014-0469-5 · Cited by 73
Metadata
- Authors
- Diener, H., Dodick, D., Aurora, S., Turkel, C., DeGryse, R., Lipton, R., Silberstein, S., & Brin, M.
- Venue
- Cephalalgia
- Publisher
- SAGE Publications
- Published
- 2010-03-17
- Volume
- 30
- Issue
- 7
- Pages
- 804-814
- ISSN
- 0333-1024 (ISSN-L)
- 1468-2982
- OpenAlex
- W4230120862
- Cited by
- 960
- References
- 5
- FWCI
- 32.50
- Type
- journal article
- Language
- en
- Open access
- closed
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- Diener, H., Dodick, D., Aurora, S., Turkel, C., DeGryse, R., Lipton, R., Silberstein, S., & Brin, M. (2010). OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. https://doi.org/10.1177/0333102410364677
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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