Summary
David Dodick, a researcher at the Mayo Clinic in Scottsdale, Arizona, is involved in a study that seeks to use Botox in preventing migraine headaches. Botox, a toxic protein commonly used in cosmetic surgery, may be able to block pain caused by migraines if it is injected directly into the affected area of the brain The study is still in Phase III, but researchers hope that the method will be able to alleviate pain in migraine sufferers. Migraine headaches affect between 12 and 15 million Americans and there is no commonly accepted treatment. This is the first study that aims to treat migraine pain in this manner.
Original source:
http://www.sciencedaily.com/releases/2005/04/050420085857.htm
Details
- -- 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.
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