Dodick told members in attendance at the American Headache Society's 47th Annual Scientific Meeting in Philadelphia that after 180 days, the BOTOX group had a bigger jump in headache-free days.
On average the 288 patients had a headache 7 1/2 days per month.
This represented six more headache-free days than at the beginning of the study, which was spread over 11 months.
Most of the women studied were women, approximately 42 years of age.
None of them were on any previous medications to prevent their migraines.
Those not in the placebo group received as many as three treatment of Botox over the eleven month period.
52% of the Botox group cut the frequency of their headaches by more than half.
Dodick said, "Botox was very well tolerated."
The treatment appears to prevent activation of a facial nerve, which is very important in migraines, he writes in a news release.
In order to block pain caused by migraines, it needs to be injected directly into the affected area of the brain. The tiny amounts of highly purified botulinum toxin protein work to block the nerve.
According to Dr. Lynne Carr Columbus, D.O. in Palm Harbor Florida, an alternative to botulinum toxin type A therapy would be medications taken by mouth such as diazepam, benztropine, clonazepam, baclofen, and others.
Dr. Columbus has used BOTOX treatments on patients who have migraines, as well as those who are suffering from cancer back pain.
BOTOX was first approved in 1989 to treat two eye muscle disorders--uncontrollable blinking (blepharospasm) and misaligned eyes (strabismus).
The migraine remedy was discovered during the 1990s when plastic surgeon Dr. William Binder was studying the ability of botulinum toxin as a way of getting rid of facial wrinkles when he made a serendipitous discovery. His clients, who suffered from migraine headaches, were being cured of them with BOTOX treatments.
One client, who had suffered from migraines since she was twelve, was migraine-free four years after being treated with BOTOX intramuscular injections.
Currently there are no therapies approved by regulatory authorities specifically for the preventative treatment of migraine patients with CHD.
In 2000, the toxin was approved to treat a neurological movement disorder that causes severe neck and shoulder contractions, known as cervical dystonia.
The FDA specifically approved BOTOX for the treatment of cervical dystonia (CD) in adults to decrease the severity of abnormal head position and neck pain associated with CD.5.
The NIH, AAN and AAO have recognized BOTOX as a safe and effective treatment for the symptomatic relief of CD.
BOTOX is also approved for the following conditions:
Blepharospasm (sustained, forced, involuntary closing of the eyelids)
Severe Primary Axillary Hyperhidrosis (excessive underarm sweating) that is inadequately managed by topical agents
Strabismus (crossed-eyes, squinting vision condition)
As an unusual side effect of the eye disorder treatment, doctors observed that BOTOX softened the vertical frown (glabellar) lines between the eyebrows that tend to make people look tired, angry or displeased. But until this improvement was actually demonstrated in clinical studies, Allergan was prohibited from making this claim for the product.
The FDA recommends that Botox Cosmetic be injected no more frequently than once every three months, and that the lowest effective dose should be used.
The U.S. Food and Drug Administration (FDA) does not currently approve BOTOX for the treatment of migraine headache disorders.
Dr. Dodick's clinical trial is the first of its kind dedicated to investigating this extremely difficult-to-treat patient population of migraine patients.
Dr. Dodick's interests related and unrelated to this trial include: basic mechanisms and pathogenesis of headache, investigation of new treatments for chronic headache, neurology education and stroke risk factor modification.
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.
Allergan, the maker of the these "improved state of mind" remedies, has created a BOTOX Portal for those interested in learning more about BOTOX Cosmetic, BOTOX Therapeutic for Select Neurological Conditions and BOTOX for Severe Underarm Sweating.
The Phase III clinical trial of Dr. Dodick's study 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.
About The Mayo Clinic in Arizona
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.
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