Status:
COMPLETED
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Lead Sponsor:
Allergan
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a 60 week study including a double-blind phase followed by an open-label extension phase.
Eligibility Criteria
Inclusion
- Frequent migraine (\>=15 headache days per month)
- \>=4 distinct headache episodes lasting \>=4 hours
- \>=50% of baseline headache days migraine/probable migraine days
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
679 Patients enrolled
Trial Details
Trial ID
NCT00156910
Start Date
February 1 2006
End Date
July 1 2008
Last Update
November 18 2013
Active Locations (2)
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1
Seattle, Washington, United States
2
Markham, Ontario, Canada