A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

This is a 60 week study including a double-blind phase followed by an open-label extension phase.

Inclusion Criteria:

• Frequent migraine (>=15 headache days per month)
• >=4 distinct headache episodes lasting >=4 hours
• >=50% of baseline headache days migraine/probable migraine days

Exclusion Criteria:

• Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype
• Any medical condition that puts the patient at increased risk with exposure to BOTOX
• Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache
• Use of prophylactic headache medication within 28 days prior to week -4
• Unremitting headache lasting continuously throughout the 4-week baseline period
• Known or suspected Temporomandibular Disorders (TMD)
• Diagnosis of fibromyalgia
• Beck depression inventory score >24 at week-4
• Psychiatric problems that may have interfered with study participation