What is the role of botulinum toxin A (onabotulinumtoxinA; BOTOX®) in migraine prevention?

Updated: Oct 21, 2019
  • Author: Jasvinder Chawla, MD, MBA; Chief Editor: Helmi L Lutsep, MD  more...
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Botulinum toxin A (onabotulinumtoxinA; BOTOX®) may be beneficial in patients with intractable, chronic migraine that has failed to respond to at least 3 conventional preventive medications. The injections are administered to the scalp and temple. They may reduce the frequency and severity of migraine attacks after 2-3 months of injections.

The injections are expensive and must be administered every 2-3 months to maintain their effectiveness. The most appropriate duration of prophylactic therapy has not been determined. In most patients who are receiving prophylaxis, therapy must be continued for at least 3-6 months.

Multiple trials of onabotulinumtoxinA for migraine prevention have been conducted, with mixed results. [115] A review by Schulte-Mattler and Martinez-Castrillo found no evidence of a beneficial effect from botulinum toxin. These authors do not recommend the widespread use of botulinum toxin therapy in headaches. [116]

More recently, however, 2 multicenter, placebo-controlled trials included in the Phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program found onabotulinumtoxinA to be effective for headache prophylaxis in adults with chronic migraine. Nearly 1400 patients were included in the results. Secondary benefits included significantly reduced headache-related disability and improved functioning, vitality, and overall health-related quality of life. [117]

In 2016, the American Academy of Neurology updated its 2008 guidelines on using botulinum toxin for brain disorders. Botulinum toxin A is now recommended for the management of chronic migraine, defined as attacks lasting 4 or more hours on at least 15 days each month for 3 months. Botulinum toxin A is not recommended for less frequent, "episodic" migraine. [118]

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