Status:
COMPLETED
A Long-term Efficacy, Safety, and Tolerability Study of BOTOX® in Patients With Chronic Migraine
Lead Sponsor:
Allergan
Conditions:
Migraine Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxinA administered for prophylaxis of headaches in patients with chronic migraine.
Eligibility Criteria
Inclusion
- Diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
Exclusion
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis
- Headache attributed to another disorder
- Infection or skin disorder at injection sites
- Previous treatment with botulinum toxin of any serotype for any reason
- Anticipated need for botulinum toxin of any type for any reason during the course of the study
- Previous participation in any botulinum toxin clinical trial
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
716 Patients enrolled
Trial Details
Trial ID
NCT01516892
Start Date
December 1 2011
End Date
November 1 2015
Last Update
January 6 2017
Active Locations (32)
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1
Arizona Neurological Institute
Scottsdale, Arizona, United States, 85255-7450
2
The Research Center of Southern California, LLC
Encinitas, California, United States, 92024
3
USC Neurology
Los Angeles, California, United States, 90033
4
UCSF Headache Center
San Francisco, California, United States, 94133