migraine once every three months. While there are currently other types of botuli- num toxin available (Myobloc, Dysport, and Xeomin) only BOTOX manufactured by Allergan is approved for treatment of chronic migraine. The mechanism by which BOTOX is effective for chronic migraine is currently unknown. It is un- likely related to the muscle or facial “pa- ralysis” desired during cosmetic treat- ments.
Greensboro's Headache Wellness
Center was a key site in one of the two principal clinical studies investigating BOTOX for chronic migraine. PREEMPT 1 and PREEMPT 2 (Phase 3 Research Evalu- ating Migraine Prophylaxis Therapy) en- rolled 1384 patients who experienced an average of 20 headaches per month. Pa- tients received two BOTOX or placebo (saline or salt water) injection treatments over a 12-week period, followed by an additional three active BOTOX treatments over the next 44-week period. Those pa- tients who received BOTOX had fewer headache days per month when compared to the placebo group (8 to 9 fewer head- ache days/month with BOTOX versus 7 fewer headache days/month with place- bo). It is important to note that even pa- tients obtaining the placebo injections had fewer headache days per month overall.
Injections: BOTOX is administered in a unique injection pattern involving 31 different sites along the forehead muscles, temples, back of head, neck, and shoul- ders. A total of 155 units of BOTOX are injected. Since BOTOX is administered using a needle, patients should be aware that there may be injection discomfort during and after the procedure.
Side Effects: While BOTOX is gener-
ally well-tolerated it is not without side effects. The most common side effects are neck pain (9%), headache (5%), muscle weakness (4%), musculoskeletal stiffness (4%), and eyelid drooping (4%).
Speed of Onset: BOTOX for chronic
migraine is effective, but it may not work quickly. The earliest response may be seen after approximately four weeks. Some patients may not respond after the first injection set. It is recommended to obtain at least two, and preferably three, treat- ments of BOTOX to determine if the medication is helpful. As BOTOX is given every three months, it may require at least
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a six month trial period to determine if BOTOX works.
Insurance Coverage: BOTOX is usu-
ally covered by commercial insurance plans provided the patient has met certain requirements. Most insurance companies in North Carolina require that the patient has tried and failed to respond to at least three different recognized oral migraine preventive medications first. They also require that the condition of “medication- overuse headache” is absent. Medication- overuse headache is a complicating condi- tion related to migraine, where overexpo- sure to pain medications worsen the mi- graine disorder. Thus, those patients who are self-treating with over-the-counter pain medications most days of the week would not be immediately eligible for BOTOX treatment.
Expert Injectors: Because of the spe- cial injection pattern used, only appropri- ately trained providers should administer the treatment.
Author's note: Headache Wellness Center (HWC) is currently participating in a clinical study using BOTOX for chronic migraine. The sponsor of the study is Al- lergan, the manufacturer of BOTOX. Our center is actively seeking individuals with frequent headaches who may qualify for the study. All evaluation, medication, and treatment would be provided without charge for those who qualify. Please con- tact our office to learn more about this opportunity.
Marshall C. Freeman, MD is the director of Headache Wellness Center (HWC) in Greensboro, NC. He is a board-certified neurologist in Adult Neurology, Neuro- muscular Medicine,
and Electrodiagnostic Medicine. He holds specialty certification in Headache Medi- cine by the United Council of Neurological Subspecialties. HWC is the oldest and longest continuously operating headache specialty practice in North Carolina, serv- ing the headache population since 1990. HWC is actively accepting new patients. Visit
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