Chronic Migraine Patients May Find Relief In Botox Therapy

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.