Botulinum Toxin Type A (Botox(R)) Reduces Frequency Of Migraines For Chronic Migraine Sufferers, According To New Study

Main Category: Headache / Migraine
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Jun 2006 - 0:00 PDT

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A new study has found that Botox(R) (Botulinum Toxin Type A) significantly reduces the number of days each month that patients with a chronic form of migraine experience migraine attacks. Migraine days declined by almost a third (26.9 percent) among the patients treated with Botox injections, compared to increasing 6 percent in patients who received placebo injections. The results will be presented on June 23rd at the 48th Annual Meeting of the American Headache Society by Frederick G. Freitag, D.O., associate director of the Diamond Headache Clinic and lead investigator of the study.

"This new data adds to previous findings suggesting that Botox can be efficacious in reducing the frequency of headache episodes in migraine patients who suffer from frequent headaches," said Dr. Freitag. "For this study, we excluded patients using a high quantity of acute pain medications since this adds to the complexity of studying a preventive treatment, and often contributes to the headache disorders. We were able to see significant improvement in the Botox-treated patients compared to placebo within one treatment cycle."

Chronic migraine is a progressive and highly disabling headache disorder characterized by headaches that occur on 15 or more days each month. It affects about 7 million Americans (approximately 2.4 percent of the general population).(i) Botox is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of headache disorders but is currently being further investigated as a prophylactic treatment in migraine patients who suffer from frequent headaches.

For this placebo-controlled, randomized and double-blind study, 36 patients who had discontinued or limited their use of acute pain medications during a 4-week baseline phase were randomized to receive one treatment with either Botox (100 U using a fixed-dose, fixed site approach) or placebo injections. The primary outcome measure was change in the number of migraine days per month.

- At the end of the 4-month study, the number of days with migraine per month declined by 26.9 percent among those treated with Botox, compared to increasing 6 percent among placebo-treated patients (p<0.001). In addition, 38.8 percent of patients treated with Botox had a 50 percent or greater reduction in migraine days, compared to 11 percent for placebo-treated patients. Acute pain medication use decreased 25.5 percent in the Botox-treated patients, while increasing 0.9 percent in the placebo group. Botox injections were well-tolerated, a total of 4 patients receiving Botox experience a total of 5 adverse events compared to 3 patients on placebo who had 9 adverse events. No event occurred in more than one patient, all were mild and transient, such that no one stopped the treatment because of adverse events. Co-researchers on this study were Seymour S. Diamond, M.D., Merle L.

Diamond, M.D. and George J. Urban, M.D., all with the Diamond Headache Clinic. This study was sponsored by an unrestricted grant from Allergan, Inc.

About the Diamond Headache Clinic

The Diamond Headache Clinic is a premiere headache and migraine health care facility located in Chicago Illinois. Founded by Dr. Seymour Diamond in 1972, the Diamond Headache Clinic is dedicated to the personalized treatment of migraine and headache pain. It is the first comprehensive private headache clinic in the world. Nationally recognized, the Diamond Clinic and Inpatient Unit is a referral center for the National Institute of Neurological and Communicative Disorders and Stroke. It also serves as a research site for the National Institutes of Health.

(i) Castillo J, Munoz P, Guitera V, Pascual J. Epidemiology of chronic daily headache in the general population. Headache 1999. 39:190:196.

Diamond Headache Clinic
http://diamondheadache.com/