When asked to rate the influence of current preventive treatment side effects, at baseline, 36.7% of topiramate subjects and 55.2% of onabotulinumtoxinA subjects stated that the question did not apply. At week 12, there was a non-significant change toward being more satisfied with the side effects experienced with the current treatment from 10% to 40.9% among topiramate subjects and from 13.8% to 45.5% among onabotulinumtoxinA subjects. This multi-center pilot study is positive for its primary endpoint of Physician Global Assessment of efficacy and demonstrated similar clinical benefits for both onabotulinumtoxinA

and topiramate in subjects with CM. These data support the conclusions of a pilot, single-center study by Mathew and Jaffri.15 The validity Epigenetics Compound Library of the Physician Global Assessment in this study was supported by significant correlations with multiple predefined secondary endpoints, including analyses of subjects’ diaries

and improvement in disability scales. The diary review demonstrated statistically significant decreases in headache days and reduction in acute medication usage from baseline. Further, there was a statistically significant increase in headache-free days. This was true for both topiramate and onabotulinumtoxinA. In addition, both interventions demonstrated statistically significant improvement Erastin price in MIDAS scores at week 12 (see Fig. 3). Finally there were potentially relevant clinical improvements in quality of life, sleep, work and recreational activities. Given the scope of these changes it appears that the Physician Global Assessment of the subject correlated Paclitaxel well with other more traditional statistical measurements of success for preventive therapy defined

in this study as secondary endpoints. Both therapies were generally well tolerated and neither had any associated serious adverse events. Interestingly, adverse events were quite similar for both medications with only slight differences were noted between the two therapies (see Table 5). Retention rates for this study were relatively high for the first 12 weeks following the baseline period. Because fewer subjects were eligible to continue in the open label extension, the statistical power of any conclusions for this phase of the study is significantly less. The open label extension should be viewed as an exploratory effort to assess if onabotulinumtoxinA might be beneficial in subjects failing to respond to topiramate. No conclusive statement can be made based on the limited number of subjects in this phase of the study. The most common reasons for study withdrawal were adverse events (53.3%; 8 out of 15) but there were no statistical differences in withdrawal rates between the onabotulinumtoxinA and topiramate groups and only minor differences in specific adverse events between the 2 groups.