Botulinum Toxin Type A Stops Tough-to-Treat Migraines: Presented at AAN
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Botulinum Toxin Type A Stops Tough-to-Treat Migraines: Presented at AAN

By Jill Stein

SAN DIEGO, C.A. -- April 5, 2006 -- Botulinum toxin type A (Botox) is an effective prophylactic treatment in patients with severe migraines that are refractory to prior preventive medications, according to data released at the 58th Annual Meeting of the American Academy of Neurology (AAN).

Alexander Mauskop, MD, director, New York Headache Center, New York, New York, United States, and colleagues analyzed data that were prospectively collected at headache centers by physicians who used botulinum toxin type A for headache prevention. He presented the data on April 5th.

Eligible patients were at least 12 years of age and were diagnosed with a primary headache disorder according to International Headache Society Classification (IHSC) guidelines.

The outcome of prophylactic treatment of botulinum toxin type A was evaluated using the Migraine Disability Assessment Scale (MIDAS), the Headache Impact Questionnaire, the Headache Pain -Specific Quality of Life Questionnaire, and the patient-reported assessment of response to treatment.

Overall, 703 patients were enrolled, and 482 patients (68.6%) were continuing botulinum toxin type A therapy at the end of the study.

Botulinum toxin type A was most often used in disabled migraine patients with at least 15 headache days per month. They had failed at least 1 preventive medication and were using concomitant preventive medications. About two thirds of patients had chronic migraine, and the average headache-related disability and average headache severity were rated as moderate to severe by 79% and 95.4% of patients, respectively.

Improvement of headache symptoms after botulinum toxin type A treatment was reported by 62.9% of patients (307/488) and 65.8% of physicians (321/488). After 3 months, MIDAS total scores decreased by a mean of 31.7 points from baseline (71.1); the number of headache days per 3 months decreased by a mean of 20.3 days from baseline (58.1 days).

Three of 703 patients (0.4%) stopped treatment because of adverse effects.

Migraine headaches affect up to 7.6% of males and 18.3% of females. In some patients, it can progress and become a chronic headache disorder.

Dr. Mauskop emphasised that the dosing and results reported in this study are specific to the formulation of botulinum toxin type A manufactured by Allergan, Inc., and added that the Allergan formulation is not interchangeable with other botulinum toxin products and cannot be converted by using a dose ratio.

The study was funded by Allergan, Inc., in Irvine, California, United States.

[Presentation title: Program To Assess Headache Treatment Strategies: Baseline and Preliminary Results From an Observational Study of Botulinum Toxin Type A Prophylactic Headache Treatment. Abstract P03.091]

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