Botulinum toxin type A as a migraine preventive treatment. For the BOTOX Migraine Clinical Research Group.
OBJECTIVE
To assess the safety and efficacy of botulinum toxin type A (BOTOX; Allergan, Inc) in the prevention of migraine.


BACKGROUND
Current migraine preventive therapies are often unsatisfactory because of their limited efficacy, adverse effects, and drug interactions. Botulinum toxin type A injections often reduce the pain associated with conditions such as cervical dystonia, achalasia, rectal fissures, and myofascial pain syndrome. An open-label, noncontrolled study of botulinum toxin type A suggested benefits for patients with migraine.


METHODS
This was a double-blind, vehicle-controlled study of 123 subjects with a history of two to eight moderate-to-severe migraine attacks per month, with or without aura. Participants were randomized to receive single administrations of vehicle or botulinum toxin type A, 25 U or 75 U, injected into multiple sites of pericranial muscles at the same visit. During a 1-month baseline period and for 3 months following injection, subjects kept daily diaries in which they recorded migraine frequency, migraine severity, and the occurrence of migraine-associated symptoms.


RESULTS
Compared with vehicle treatment, subjects in the 25-U botulinum toxin type A treatment group showed significantly fewer migraine attacks per month, a reduced maximum severity of migraines, a reduced number of days using acute migraine medications, and reduced incidence of migraine-associated vomiting. Both the 25-U and 75-U botulinum toxin type A groups were significantly better than the vehicle group on subject global assessment. Botulinum toxin A treatment was well tolerated, with only the 75-U treatment group exhibiting a significantly higher rate of treatment-related adverse events than vehicle.


CONCLUSIONS
Pericranial injection of botulinum toxin type A, 25 U, was found to be a safe treatment that significantly reduced migraine frequency, migraine severity, acute medication usage, and associated vomiting.
Silberstein
S
S
Thomas Jefferson University School of Medicine, Philadelphia, PA, USA.
Mathew
N
N
Saper
J
J
Jenkins
S
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006257:Head; D006801:Humans; D015994:Incidence; D007273:Injections, Intramuscular; D008499:Medical Records; D008875:Middle Aged; D008881:Migraine Disorders / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A