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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
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