Conflicts of Interest: Dr. Roger Cady: Consultant for GlaxoSmithKline, Merck, Ortho-McNeil. Research grants from Allergan, Endo Pharmaceuticals, GlaxoSmithKline, Merck, and Wyeth. Dr. John Porter: Consulting Speakers panel with Novartis, Forest, Biogen, UCB Pharma, Pfizer, TEVA. Dr. Andrew Blumenfeld: Consultant, speaker's bureau, and research grants from Allergan. Dr. Curtis Schreiber and Dr. Kathleen Farmer: None to disclose.
A Multi-Center Double-Blind Pilot Comparison of OnabotulinumtoxinA and Topiramate for the Prophylactic Treatment of Chronic Migraine
Article first published online: 10 NOV 2010
© 2010 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 51, Issue 1, pages 21–32, January 2011
How to Cite
Cady, R. K., Schreiber, C. P., Porter, J. A.H., Blumenfeld, A. M. and Farmer, K. U. (2011), A Multi-Center Double-Blind Pilot Comparison of OnabotulinumtoxinA and Topiramate for the Prophylactic Treatment of Chronic Migraine. Headache: The Journal of Head and Face Pain, 51: 21–32. doi: 10.1111/j.1526-4610.2010.01796.x
- Issue published online: 3 JAN 2011
- Article first published online: 10 NOV 2010
- Accepted for publication September 19, 2010.
- migraine prophylaxis;
- chronic migraine;
- physician global assessment
Objective.— This multi-center pilot study compared the efficacy of onabotulinumtoxinA with topiramate (a Food and Drug Administration approved and widely accepted treatment for prevention of migraine) in individuals with chronic migraine (CM).
Methods.— A total of 59 subjects with CM were randomly assigned to one of 2 groups: Group 1 (n = 30) received topiramate plus placebo injections, Group 2 (n = 29) received onabotulinumtoxinA injections plus placebo tablets. Subjects maintained daily headache diaries over a 4-week baseline period and a 12-week active study period. The primary endpoint was the Physician Global Assessment, which measured the treatment responder rate and indicated improvement in both groups over 12 weeks. Secondary endpoints, measured at weeks 4 and 12, included headache days per month, migraine days, headache-free days, days on acute medication, severity of headache episodes, Migraine Impact & Disability Assessment, Headache Impact Test, effectiveness of and satisfaction with current treatment on the amount of medication needed, and the frequency and severity of migraine symptoms. At 12 weeks subjects were re-evaluated and tapered off oral study medications over a 2-week time period. Subjects not reporting a >50% reduction of headache frequency at 12 weeks were invited to participate in a 12-week open label extension study with onabotulinumtoxinA. Of these, 20 subjects, 9 from the Topiramate Group and 11 from the OnabotulinumtoxinA Group, volunteered for this extension from weeks 14 to 26.
Results.— This study demonstrated positive benefit for both onabotulinumtoxinA and topiramate in subjects with CM. Overall, the results were statistically significant within groups but not between groups. By week 26, subjects had a reduction of headache days per month compared with baseline. This was a significant within-group finding.
Conclusion.— OnabotulinumtoxinA and topiramate demonstrated similar efficacy for subjects with CM as determined by Global Physician Assessment and supported by multiple secondary endpoint measures.