Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

Komparator placebo: Placebo

Subjects are randomized to receive Placebo which is inactive saline (sterile salt water solution). The Subjects are injected with a comparable amount of placebo solution (2cc-3cc) as received by those randomized to receive active study drug. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.

Inny: Placebo

subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.

Inne nazwy:

• Solankowy

Aktywny komparator: Botox

Subjects are randomized to receive Active study drug Botox (onobotulinumtoxinA). The Botox is prepare by diluting 100units of toxin /1cc Saline. The Subjects are injected with 200-300units of units of Botox which is 2cc-3cc of solution. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.

Lek: Botox

subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size.

Inne nazwy:

• onobotulinumtoxinA

Mean Number of Days of Decrease in Pain Level Using VAS

Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.

Number of Participants Satisfied With Treatment

Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:

No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved

This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.