Scientific Studies Confirm The Value Of Botulinum Toxin Type A (Botox) In Treating And Preventing Chronic Migraine

Main Category: Headache / Migraine
Also Included In: Cosmetic Medicine / Plastic Surgery
Article Date: 16 Sep 2009 - 1:00 PDT

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Four separate studies[i] representing the findings of clinical trials in the U.S., Canada and Europe have confirmed the value of onabotulinumtoxinA in treating and preventing chronic migraine in adults. These studies found that treatment with botulinum toxin type A was associated with significantly fewer headache days, less headache-related disability, and significantly improved quality of life.

Results of the studies are being presented this week at the 14th International Headache Congress hosted in Philadelphia by the American Headache Society (AHS).

"This is an important advance in migraine prevention ," said David Dodick, M.D., lead author of the study. "Patients afflicted with chronic migraine are severely disabled. Very few preventive treatments have been investigated for chronic migraine, and none is yet approved." Of the 36 million Americans estimated to have migraine, about 6 million suffer from chronic migraine; most are undiagnosed and inadequately treated.

One of the four studies (Dodick et al.)[ii], a phase III double-blind, parallel-group, placebo-controlled multicenter phase 3 study involving 705 adults with chronic migraine at 66 sites, found that prophylactic treatment with onabotulinumtoxinA resulted in statistically and clinically meaningful improvements for all endpoints.

"Subjects were randomized to receive onabotulinumtoxinA or placebo injections every 12 weeks to determine changes in the number of headache days at the end of 24 weeks," Dr. Dodick said. "We found that the group on onabotulinumtoxinA not only experienced fewer headache days, but also showed significant reduction in migraine episodes, total hours of headache per month, and headache-related disability. This resulted in improved functioning and quality of life.

A second study by Lipton et al.[iii] comparing quality of life measurements for subjects on onabotulinumtoxinA vs. placebo found the magnitude of the improvement in headache-related quality of life to be "highly statistically significant and reflects clinically meaningful improvements in functioning and vitality, and a decrease in psychological distress." "Migraine is an extremely debilitating medical condition for many sufferers," said Richard B. Lipton, MD, lead author of the study and Director of the Montefiore Headache Center in New York City. "The relief that onabotulinumtoxinA brings and the enormous improvement in functioning and vitality is striking."

More than 400 scientific papers and posters are to be presented during the IHC/AHS meeting which is expected to draw some 1,200 migraine specialists and scientists from around the globe. The meeting is the world's largest professional conference on migraine and headache-related diseases.

[i] "Botulinum neurotoxin type A for treatment of chronic migraine: PREEMPT 1 trial double-blind phase"
Aurora SK et al
"Botulinum neurotoxin type A for treatment of chronic migraine: PREEMPT 2 trial double-blind phase"
Dodick DW et al
"Botulinum neurotoxin type A for treatment of chronic migraine: analysis of the PREEMPT chronic migraine subgroup with baseline acute headache medication overuse," Silberstein SD et al.
"Botulinum neurotoxin type A treatment improves health-related quality of life and reduces the impact of chronic migraine: results from the double-blind phase of the PREEMPT clinical program," Lipton RB et al.

[ii] "Botulinum neurotoxin type A for treatment of chronic migraine: PREEMPT 2 trial double-blind phase" Dodick DW1, Smith TR2, Becker WJ3, Gendolla A4, Relja M5, Martin V6, Reyes C7, Lei X7 and Turkel CC7 1Neurology, Mayo Clinic Arizona, Phoenix, AZ, USA; 2Ryan Headache Center, St. Louis, MO, USA; 3Clinical Neurosciences, University of Calgary, Calgary, AB, Canada; 4Kliniken Ruhrhalbinsel, Essen, Germany; 5Neurology, Medical School University of Zagreb, Croatia; 6Internal Medicine, University of Cincinnati, Cincinnati, OH, USA; 7Allergan, Inc., Irvine, CA, USA

[iii] "Botulinum neurotoxin type A treatment improves health-related quality of life and reduces the impact of chronic migraine: results from the double-blind phase of the PREEMPT clinical program"
Lipton RB1, Varon S2, Grosberg B3, McAllister PJ4, Freitag F5, DeGryse RE2 and Turkel CC2 1Neurology, Albert Einstein College of Medicine, Bronx, NY, USA; 2Allergan, Inc., Irvine, CA, USA; 3Neurology, Montefiore Headache Center, Bronx, NY, USA; 4Associated Neurologists of Southern Connecticut, Fairfield, CT, USA; 5Diamond Headache Clinic, Chicago, IL, USA

Source
International Headache Society