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BOTOX® Reduces Headache Frequency
Frishberg, et al.
Posted: October 2005  
Presented at the 5th International Conference on Basic and
Therapeutic Aspects of Botulinum and Tetanus Toxins
Denver, CO; June 23-25, 2005

Study Design:  This was a double-blind exploratory study of patients with CDH from 13 North American study centers.

Results:  A total of 355 patients with chronic daily headache (CDH) received injections of BOTOX® (BoNT-A) or placebo. A significantly higher percentage of BoNT-A patients had a decrease from baseline in the frequency of headache days at day 180. At the primary timepoint (day 180), BoNT-A patients had a -6.1 change from baseline in headache frequency per 30 days. In contrast, patients receiving placebo had a -3.1 change from baseline. This difference was statistically significant.

BOTOX® is an Effective Stand-alone Prophylaxis Agent for Headache:  Data from a subgroup of patients not taking headache prophylaxis was also analyzed. After 2 treatment cycles, the maximum change in mean headache frequency per 30 days was -7.8 for the BoNT-A group compared with -4.5 for the placebo group. Between-group differences favoring BoNT-A continued to improve after the third treatment cycle. Compared to the placebo group, there were also significant reductions in the BoNT-A group from baseline in headache frequency and headache severity for most time points from day 150 through day 270.

Safety and Tolerability:  The BoNT-A treatment was well tolerated. Of 173 BoNT-A patients, only 2.3% discontinued the study due to adverse events.

Conclusion:  BOTOX® appears to be an effective treatment option for patients with CDH. Follow-up analysis of a specific subpopulation indicates that BOTOX® is effective in patients with CDH who are not using other prophylactic headache treatments.