Chronic Migraine Patients May Find Relief in Botox Therapy

Thursday, April 14, 2005

SCOTTSDALE, Ariz. — New research suggests BOTOX (botulinun toxin type A) may significantly reduce frequency of headache attacks in migraine patients suffering from chronic daily headaches (CHD).

David W. Dodick, M.D., a neurologist at Mayo Clinic is involved in a Phase II study and will be lead investigator for Phase III. The clinical trial, sponsored by Allergan Inc., a health care company headquartered in Irvine Calif., was published in the April 2005 issue of the Journal of Headache.

Between 12 and 15 million Americans currently suffer from CHD, a highly disabling headache disorder characterized by 16 or more days of headache per month. Currently there are no therapies approved by regulatory authorities specifically for the preventative treatment of migraine patients with CHD. This clinical trial is the first of its kind dedicated to investigating this extremely difficult-to-treat patient population of migraine patients. BOTOX is a medical product that contains tiny amounts of highly purified botulinum toxin protein and is administered in small doses by injection directly into the affected area and works by blocking the nerve.

The Phase III clinical trial is currently scheduled to begin in late 2005 and plans to investigate the safety and efficacy of BOTOX as a preventative therapy in a subset of migraine patients with CDH.

The U.S. Food and Drug Administration (FDA) does not currently approve BOTOX for the treatment of any headache disorder.

Mayo Clinic is a private group practice of medicine dedicated to providing diagnosis and treatment of patient illnesses through a systematic focus on individual patient needs. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 208-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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