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news.An exploratory phase II study has shown that Allergan's Botox significantly reduced the frequency of headache attacks in migraine patients suffering from chronic daily headache when compared to placebo.
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This study is one of multiple phase II clinical trials that Allergan has sponsored to explore the use of its Botox (botulinum toxin type A) product to treat various forms of headache in an effort to identify an appropriate protocol and patient group to guide its phase III program.
The difference on the primary efficacy measure (change from baseline in the number of headache-free days) compared to placebo did not reach statistical significance. However, significant differences compared to placebo were demonstrated on other key efficacy measures.
For example, within 30 days following the first treatment, Botox-treated patients experienced significantly fewer headaches than placebo-treated patients, an effect that was sustained throughout the nine-month study. The difference was greatest at day 180, when Botox-treated patients experienced an average of 7.1 fewer headache attacks per 30 day period, compared to 3.7 fewer attacks among placebo-treated patients.
In addition, a significantly higher percentage of Botox-treated patients had a decrease from baseline of greater than or equal to 50% in the frequency of headache days.
Differences on key efficacy measures in favor of Botox were even more evident in a subgroup analysis of study patients who were not taking other prophylactic medications to treat their headaches.
Based on these phase II findings in chronic daily headache (CDH), Allergan has reached an agreement with the FDA to move forward with a large phase III clinical trial program, currently scheduled to begin in late 2005, to investigate the safety and efficacy of Botox as a prophylactic therapy in a subset of migraine patients with CDH.
There are no therapies approved by regulatory authorities specifically for the prophylactic treatment of migraine patients with CDH. Classes of drugs currently used for this purpose include beta-blockers, calcium channel blockers, serotonin antagonists, antidepressants, nonsteroidal anti-inflammatory drugs, and antiepileptic drugs.
Botox is a medical product that contains tiny amounts of highly purified botulinum toxin protein refined from a bacterium. The product is administered in small therapeutic doses by injection directly into the affected area, and works by blocking the overactive nerve.
Botox therapy, commonly known for its frown line reduction treatment, Botox Cosmetics, has been approved in a number of indications including cervical dystonia, crossed eyes (strabismus), uncontrollable eye blinking (blepharospasm) and excessive underarm sweating. In the US, it is also currently being investigated in medical conditions including migraine and headache, post-stroke spasticity, and overactive bladder.