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Botulinum Toxin Type A (BOTOX®) for the
Prophylactic Treatment of Chronic Daily Headache:
A Randomized, Double-Blind, Placebo-Controlled Trial
Mathew NT; Frishberg BM; Gawel M, et al.
Posted: May 2005  
Headache 2005;45:293-307

Objective:  The objective of this study was to evaluate the safety and efficacy of botulinum toxin type A (BoNT-A; BOTOX®, Allergan Inc.) for the prophylactic treatment of chronic daily headache (CDH).

Design and Methods:   This was an 11-month, randomized double-blind, placebo-controlled study of BoNT-A for the treatment of patients aged 18 to 65 years old with 16 or more headache days per 30 days conducted at 13 North American study centers. Eligible patients from both the placebo responder and placebo nonresponder groups were injected with BoNT-A or placebo every 90 days and assessed every 30 days for 9 months, a period encompassing three treatment cycles.

Conclusions:   BoNt-A treatment resulted in patients having, on average, approximately seven more headache-free days compared to baseline. Although at the primary time point (day 180) the BoNT-A treatment resulted in a 1.5 between-group difference compared to placebo, this difference was not statistically significant. The treatment met secondary efficacy outcome measures, including the percentage of patients experiencing a 50% or more decrease in the frequency of headache days, in addition to statistically significant reductions in headache frequency. BoNT-A was also well tolerated in patients with CDH.